For orthotic, prosthetic, bracing, and rehab-equipment designers and buyers

Orthotics, Prosthetics & Rehab

Wide reference image of a die-cut microcellular polyurethane orthotic insole pad, a firm crosslinked polyethylene structural layer, and a soft EVA cushion staged as a soft-to-firm orthotic and bracing padding stack

The person wearing an orthotic never thinks about durometer or compression set. They just know whether it still feels right at the end of a long day. H-O Products converts the cushioning, pressure-redistribution, and liner foams that decide that answer, for orthotics, prostheses, braces, and rehab equipment, built to your drawing from cushioning material grades commonly used against the body.

Built for: orthotic insole and footbed padding, prosthetic socket and liner cushioning, bracing and support padding, and rehab and therapy equipment cushioning, with the soft-to-firm stack that redistributes pressure and cushions the body for long wear.

01
3 jobs
Orthotic, brace, and rehab, one converter
Orthotic and insole padding, bracing and support padding, and rehab and therapy equipment cushioning. Three padding jobs across the orthotic, prosthetic, and rehab workflow, die-cut to your drawing.
02
5 families
Cushioning material families
Microcellular polyurethane, resilient polyurethane foams, firm crosslinked polyethylene, softer EVA, and the soft-to-firm stack that builds the cushion and the structure together.
03
1 goal
Pressure redistribution
The job of a body-contact foam is to spread load off high-pressure points and cushion the body comfortably for long wear, which means matching the firmness and the recovery to the body site and the load.
04
3
Designations referenced
Material grades are referenced to ISO 10993, USP Class VI, and an FDA contact basis by designation, with the maker TDS and the relevant ASTM foam test methods cited inline.
Made in Winsted, CT · Family-owned since 1971 · ISO 9001:2015 certified organization
Finished die-cut PORON medical microcellular polyurethane parts converted by H-O Products, on release liner ready to ship
How it works
  1. 1
    Send drawing
    Upload a DXF, STEP, or PDF, or describe the orthotic, brace, or rehab part, the body site, and the load. A sample part or a foot or limb profile works too.
  2. 2
    Material review
    Engineering reviews the body site and the load, the firmness and the soft-to-firm stack, the durability and recovery over the wear, the contact basis (ISO 10993 / USP Class VI / FDA, by designation) against the maker TDS, and the adhesive and build.
  3. 3
    Prototype
    Samples typically ship in 3–5 business days for common configurations on materials we keep on hand. Made-to-order; minimum run quantities apply and vary by material and part.
  4. 4
    Production
    Standard production runs ship about 2 weeks after drawing approval, including laminated soft-to-firm stacks and skived or contoured profiles. Ongoing parts run with material traceability and lot-code documentation aligned to your requirements.
Quick Answer

To choose a cushioning foam for an orthotic, prosthesis, brace, or rehab device, start with the body site and the load. For the skin-side comfort cushion that redistributes pressure, specify a PORON medical microcellular polyurethane, the industry-standard orthotic cushioning with controlled, low-compression-set force-deflection. The remaining zones and duties are mapped in the When-to-spec list on this page. Values are per the TDS on file; see the material reference below for ordering details.

Standards & Designations

ISO 10993-1 (biological evaluation of medical devices, contact classification) · ISO 10993-5 (cytotoxicity) · ISO 10993-10 (sensitization, for skin-contact padding) · USP Class VI / USP <88> (in-vivo plastics reactivity, by designation) · FDA 21 CFR 177.2600 (a composition basis, not a device clearance) · ASTM D3574 (flexible cellular urethane foam: density, IFD, compression set, tensile/tear) · ASTM D2240 (durometer, where applicable) · ASTM D1056 (cellular rubber) · ISO 9001:2015 (H-O converting QMS, not a device clearance).

The material maker evaluates a grade against the biological frameworks; H-O is an ISO 9001:2015 certified converter and does not certify finished devices.

When To Spec What
Where it lives

Application Zones

Orthotic, prosthetic, and rehab padding does the same fundamental job in three places: redistribute pressure off the high points and cushion the body comfortably for long wear. In an orthotic or insole, the foam cushions the foot and spreads plantar pressure across a footbed; in a brace, support, or prosthetic socket, it cushions the limb against the rigid structure and offloads bony prominences; in rehab and therapy equipment, it cushions a seat, a positioning pad, or a support.

Across all three, the right part is usually a soft-to-firm stack: a comfort foam on the body, a firm foam behind it for structure and to resist bottoming. Click a tab to see the part, the cushioning and contact considerations, and the families H-O converts for that zone.

Close-up of a microcellular polyurethane orthotic top cover laminated over a firm crosslinked polyethylene insole base

Orthotic, insole, and footbed padding

Designations: ISO 10993, USP Class VI, FDA (by designation)Methods: ASTM D3574, ASTM D1056

An orthotic or insole is a layered foam part that cushions the foot and redistributes plantar pressure across the footbed so high-pressure points (the heel, the metatarsal heads) carry less load. The controlling properties are the firmness and force-deflection (soft enough to cushion and conform, firm enough not to bottom out under body weight), the recovery over thousands of steps a day, and a clean top surface against the foot.

The standard build is a soft-to-firm stack: a microcellular polyurethane comfort top (PORON medical) that cushions and redistributes pressure with low compression set, over a firm crosslinked polyethylene base that holds the orthotic shape and resists bottoming, sometimes with an EVA cushion layer between. Match the comfort-layer firmness to the foot and the load, and the base firmness to the structure.

State the body weight, the activity, and any pressure-offloading need. Foam properties are characterized per ASTM D3574 (density, IFD, compression set); grade-specific values are per the maker TDS.

PORON medical microcellular polyurethaneThe industry-standard orthotic comfort top: controlled, soft force-deflection at low stress, low compression set, redistributes plantar pressure and recovers over the wear. Referenced to ISO 10993 / USP Class VI by designation. [1]
Crosslinked polyethylene foamFirm, fine-celled base layer that holds the orthotic shape and resists bottoming under body weight. Die-cut and skived to the footbed contour. [7]
EVA foamA softer, resilient cushion layer for the footbed, used between the comfort top and the firm base or as a midsole cushion. Die-cut to the insole outline.
Soft polyurethane foam (HyPUR-cel S)A soft, conforming polyurethane cushion for a high-comfort top or an accommodative footbed. Die-cut and laminated into the soft-to-firm stack.
Macro product photo of a microcellular polyurethane brace liner pad and a resilient polyurethane support cushion on a clean studio background

Bracing, support, and prosthetic-socket padding

Properties: cushioning, offloading, conformabilityTest methods: ASTM D3574, ASTM D1056

Padding and liners for braces, supports, and prosthetic sockets cushion the limb against the rigid structure and redistribute pressure off bony prominences so the device is comfortable and does not cause a pressure point. The controlling properties are conformability (the pad has to wrap the limb and take up the gap between the limb and the rigid shell), pressure offloading (it must spread load off the bony high points), recovery over long wear, and a skin-contact surface.

A microcellular polyurethane (PORON medical) is the offloading comfort layer because it redistributes pressure with low set; a resilient or soft polyurethane foam (HyPUR-cel R or S) gives a conforming cushion or liner; and where the pad sits directly on skin, it is a contact part referenced to the skin endpoints. State the body site, the bony prominences to offload, the limb contour, and whether the pad is skin-contact.

Foam properties are characterized per ASTM D3574; grade-specific values are per the maker TDS.

PORON medical microcellular polyurethaneThe offloading comfort layer for a brace or socket: redistributes pressure off bony prominences with low compression set and recovers over long wear. Referenced to ISO 10993 / USP Class VI by designation. [3]
Resilient polyurethane foam (HyPUR-cel R)A resilient cushioning foam with energy return for a brace or support liner that cushions the limb and springs back. Die-cut and contoured to the limb.
Soft polyurethane foam (HyPUR-cel S)A soft, conforming polyurethane liner that wraps the limb and takes up the gap to the rigid shell. Die-cut to the socket or brace contour.
Crosslinked polyethylene foamA firm structural pad or shell liner where the padding also has to hold a shape or carry load. Die-cut and skived to the brace contour.
Resilient high-density foam rehab and therapy equipment padding staged on mobility support equipment

Rehab, mobility, and therapy equipment padding

Function: cushion, position, and supportMedia: resilient and high-density foam

Rehab, mobility, and therapy equipment uses cushioning and liners for seats, positioning pads, support cushions, and contact surfaces, where the part cushions the body, holds a position, and lasts through repeated use. The controlling properties are the cushioning and load support (the foam must cushion comfortably and carry the load without bottoming), the durability and recovery over long, repeated use, and a cleanable contact surface.

A resilient polyurethane foam (HyPUR-cel R) cushions a seat or support and springs back; a general-purpose polyurethane foam (HyPUR-cel T) is the cost-effective option for firmer builds — verify load behavior per the maker TDS; a firm crosslinked polyethylene gives a structural base; and an EVA gives a softer cushion layer. The soft-to-firm stack applies here too. State the equipment, the load and the body site, the durability the use demands, and whether the surface is cleaned.

Foam properties are characterized per ASTM D3574; grade-specific values are per the maker TDS.

Resilient polyurethane foam (HyPUR-cel R)A resilient cushioning foam with energy return for rehab seating, positioning, and support cushions that cushion and spring back over repeated use. Die-cut to the part. [7]
General-purpose polyurethane foam (HyPUR-cel T)A general-purpose polyurethane foam for support cushions and load-bearing pads; grade and density per the maker TDS. Die-cut and gauged to the load.
Crosslinked polyethylene foamA firm structural base or positioning core that holds a shape under load. Die-cut and skived to the equipment contour.
EVA foamA softer, resilient cushion layer or contact surface in a seating or positioning pad. Die-cut to the part; paired with a firmer foam for the soft-to-firm stack.
Spec discipline

Six decisions that drive your cushioning foam spec

A body-contact cushioning foam is not a single-property choice. The right pad satisfies several constraints at once, and getting the firmness or the durability wrong produces a cushion that bottoms out under load, one that flattens after a few weeks, or a pressure point that the part was meant to relieve. Read the six factors before reaching for a material.

Specification principle

Match the firmness to the body site and the load, and build a soft-to-firm stack. One firmness rarely does the whole job: too soft and it bottoms out, too firm and it does not cushion. The reliable answer is a stack, a comfort foam on the body and a firm foam behind it. Decide the body site and the load first, then the firmness and the stack, then the durability, then the contact basis. H-O references material grades by designation; the maker evaluates the grade and the device maker owns the finished-device file.

Soft ↔ Firm
The stack does what one foam cannot

A comfort foam cushions; a firm foam holds shape and resists bottoming. Put the soft microcellular polyurethane on the body to cushion and redistribute pressure, and the firm crosslinked polyethylene behind it for structure, and the part cushions without bottoming out. Specifying one firmness to do both jobs is the most common cushioning miss.

PORON medical microcellular PU Force-defl.Soft, low stress Comp. setLow (ASTM D3574) JobPressure redistribution BasisISO 10993 (designation)

Read the six factors below in order. The body site and job narrow the family; the pressure and load set the firmness; the soft-to-firm stack puts comfort and structure together; the durability sets the grade for the wear; the contact basis adds its constraint. Selecting one factor at a time and re-checking the others is the discipline.

Show all 6 selection factors tap to expand
1

The body site and job decide the family

The first decision is what the foam is padding and where on the body. An orthotic or insole cushions the foot and redistributes plantar pressure, wanting a microcellular polyurethane comfort top over a firm crosslinked polyethylene base; a brace, support, or socket cushions the limb and offloads bony prominences, wanting a microcellular polyurethane offloading layer and a conforming polyurethane liner; rehab and therapy equipment cushions a seat or a support, wanting a resilient or high-density polyurethane foam.

Each site has a different load, contour, and durability demand. Decide the site and the job first; it picks the family before the firmness, the stack, and the durability refine the grade.

The three sites map to overlapping families, but the load, the contour, and the wear differ, so the grade and the stack are chosen per site.
2

Pressure and load set the firmness

The job of a body-contact foam is to redistribute pressure, so the firmness has to match the body weight and the load at the site. Too soft a foam bottoms out under load, so it stops cushioning and transmits the pressure straight through; too firm a foam does not deform enough to spread the load, so it cushions poorly and can itself create a pressure point.

The right firmness deforms enough to spread the load across the contact area without bottoming, and a higher body weight or load needs a firmer or denser foam (or a thicker one). State the body weight, the load at the site, and any high-pressure point to offload, so the firmness and density match. For a heavier load or a load-bearing pad, a higher-density polyurethane carries it; for a comfort cushion, a soft microcellular polyurethane redistributes it.

Force-deflection (IFD/CFD) and density are maker-TDS properties characterized per ASTM D3574; this page frames them qualitatively and defers grade-specific values to the TDS on file.
3

The soft-to-firm stack does what one foam cannot

One firmness rarely satisfies both comfort and structure, so most orthotic and bracing parts are a soft-to-firm stack. Put a soft comfort foam (microcellular polyurethane) on the body to cushion and redistribute pressure, and a firm foam (crosslinked polyethylene) behind it to hold the shape, carry the load, and resist bottoming; an EVA or resilient polyurethane can sit between as a transition cushion.

The comfort layer feels right and offloads the high points; the firm layer gives the structure and stops the soft layer bottoming out. Decide the layers, the firmness of each, and the order (body outward), and H-O laminates the stack and it as one part. Specifying a single firmness to do both jobs is the most common cushioning miss, producing a pad that either bottoms out or does not cushion.

Lamination of a soft-to-firm stack and or skived contouring are H-O converting operations; the layer firmnesses are maker-TDS properties referenced by designation.
4

Durability and recovery set the grade for the wear

A cushioning part is worn or used heavily over a long life, so it has to recover and not flatten. The controlling property is compression set: a foam not chosen for low set gradually loses its thickness and recovery under the repeated load (thousands of steps a day in an insole, constant pressure in a brace, repeated use in rehab equipment), so it flattens and stops cushioning.

A microcellular polyurethane (PORON medical) is chosen for orthotic and bracing comfort because it has low compression set and recovers over the wear; a resilient or high-density polyurethane lasts under a heavier or more repeated load. State the wear (steps per day, hours of wear, cycles of use) and the expected life, so the grade recovers over it. A cushion that takes a set flattens and re-creates the pressure point it was meant to relieve, which is a common cushioning failure.

Compression set and fatigue are maker-TDS properties characterized per ASTM D3574; this page frames them qualitatively and defers grade-specific limits to the TDS on file.
5

Contact basis is set by whether the pad touches skin

Much orthotic, bracing, and rehab padding sits directly against skin for long periods, so the contact basis matters. Define the contact (skin-contact comfort layer, or internal structural layer) and the duration, because that sets which biological-evaluation designations the material grade is referenced to.

A skin-contact comfort pad worn for prolonged periods most often references ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), and ISO 10993-23 (irritation); a USP Class VI designation is a useful material-level reference; an FDA-grade designation describes a composition and contact basis.

The structural foam behind the comfort layer has a lighter contact requirement. State whether the pad is skin-contact, the wear duration, and the basis you need, and H-O references a grade that carries it. The material maker evaluates the grade; the device maker owns the finished-device biocompatibility.

Contact type and duration follow ISO 10993-1; for a skin-contact comfort pad the -10 and -23 endpoints matter most, referenced at the material level, not asserted as a device clearance by H-O.
6

Adhesive, profile, and build finish the part

The last decisions are how the part is shaped and assembled. A flat pad is to its outline; a contoured footbed or socket liner is skived or profiled to a varying thickness; a soft-to-firm stack is laminated and as one piece; and a pad on a shell or a footbed is held by a pressure-sensitive adhesive on one face, kiss-cut on a release liner so it can peel and place.

State the outline and any contour or skive, the layers and their order, whether the part carries an adhesive and on which face, and how it ships, because that defines the converted part. Where the comfort layer is skin-contact, name the contact basis so any adhesive near it is referenced too. H-O die-cuts, skives, laminates the soft-to-firm stack, and kiss-cuts the part on liner to your drawing.

Die-cut, skive, lamination, and kiss-cut-on-liner are H-O converting operations; a skin-adjacent adhesive is referenced to the relevant ISO 10993 part at the material level when specified.
Decision support
Body-Contact Cushioning·Interactive Selection

Specification Tools

Two tools to take you from "I have a body site to cushion" to here is the foam to put on the drawing: a cushioning durometer and pressure picker that maps your body site, load, and durability to a foam family and a firmness direction, and a side-by-side comparison matrix of every cushioning and structural foam family on this page.

1. Cushioning durometer & pressure picker by body site, load, and durability

Pick the body site and job, the load or body weight, and the durability the use demands. The picker maps them to a recommended foam family and a soft-to-firm direction with a reason. Conservative starting point; confirm the grade, firmness, density, and contact basis against the maker TDS for your parts.

Pick a body site, load, and durability to see a recommendation

The result returns a recommended cushioning or structural foam family and a soft-to-firm direction, the reason it fits your body site and load, and a one-click path to the product category and the quote form. Grades are referenced by designation; confirm the firmness, density, and contact basis on the maker TDS.

2. Side-by-side: cushioning & structural foam comparison matrix

Every foam family called out on this page, grouped by role, with construction, the duty it fits, the firmness note, and the contact-designation note. Click a column header to sort. Click any material name to jump to its accordion entry and reference.

Filter
Material Construction Role Firmness Form factor Best for
Comfort cushioning (microcellular & PU foams)
PORON medical microcellular PULow set, pressure redistribution Microcellular PU Comfort top Soft Orthotic / brace comfort layer
Resilient PU foam (HyPUR-cel R)Energy return, springs back Resilient PU Cushion Medium Brace / rehab cushion
Soft PU foam (HyPUR-cel S)Soft, conforming Soft PU Liner Soft Conforming socket / brace liner
High-density PU foam (HyPUR-cel T)Carries higher load High-density PU Load cushion Firm Load-bearing support cushion
Structural & closed-cell foams
Crosslinked polyethylene foamFirm, holds shape Closed-cell PE Structural base Firm Orthotic base, resists bottoming
EVA foamSofter, resilient Closed-cell EVA Cushion layer Soft-medium Midsole / transition cushion
Orientation & clean-surface families
Polyurethane foam (family)Broad PU cushioning range Polyurethane foam Cushion Soft to firm Broad cushioning orientation
FDA-grade white elastomerClean white surface FDA-grade Contact surface Per grade Clean white contact surface
Construction and role are from the maker designations and the H-O converting envelope; firmness is a relative direction, and grade-specific force-deflection and density are maker-TDS properties characterized per ASTM D3574. Designation references (ISO 10993, USP Class VI, FDA contact basis) are at the material level; H-O is an ISO 9001:2015 certified converter and does not certify finished devices. Confirm grade-specific values against the TDS on file.
Found your candidate family? The fastest next step is the drawing: H-O reviews it against these selections and comes back with a manufacturable option and the TDS.
Already know your spec?

Skip ahead and request your engineering review now

If your drawing already calls out a specific microcellular polyurethane, crosslinked polyethylene, EVA, or resilient polyurethane foam, or a soft-to-firm stack, send it over for engineering review.

What goes wrong in the field

Failure modes the designer designs against

Cushioning-foam failures are predictable, and most are about firmness and durability: a foam that bottoms out under load, one that flattens after weeks of wear, a single firmness asked to do two jobs, a pressure point that returns, or a skin-contact basis that was never stated. The fixes are at spec and in the converted construction.

Field caution

Cushioning parts rarely fail on day one. A foam that bottoms out under load, a cushion that takes a set and flattens over weeks of wear, and a pressure point that returns when the comfort layer compresses all show up after the part has been worn or used. The fix is at spec, in the firmness, the soft-to-firm stack, and the durability grade, not after the pressure sore appears.

Show all 5 failure modes tap to expand

1. The foam bottoms out under load and stops cushioning

A cushion feels soft and comfortable unloaded, then under body weight it compresses fully and the user feels the hard surface through it.

The mechanism is bottoming out: a foam too soft or too thin for the load compresses to its limit, so it no longer deforms to spread the pressure and transmits the load straight through. The fix: match the firmness and the thickness to the load, a firmer or denser foam, or a soft-to-firm stack with a firm crosslinked polyethylene base behind the soft comfort layer, so the part deforms to cushion without reaching its limit.

A higher body weight or a load-bearing pad needs a higher-density polyurethane. State the body weight and the load so the firmness and gauge are sized correctly. Force-deflection and density are characterized per ASTM D3574; grade values are per the TDS on file. [7]

2. The cushion flattens after a few weeks and a pressure point returns

A pad cushions well when new, then over weeks of wear it loses its thickness, stops cushioning, and the pressure point it was meant to relieve returns. The mechanism is compression set: a foam not chosen for low set gradually deforms permanently under the repeated load (thousands of steps a day, constant brace pressure), so it flattens and no longer offloads the high point.

The fix: choose a cushioning grade with low compression set, a microcellular polyurethane (PORON medical) is selected for orthotic and bracing comfort because it recovers over the wear, and a resilient or high-density polyurethane lasts under a heavier or more repeated load. State the wear (steps per day, hours, cycles) and the expected life so the grade recovers over it.

A cushion that takes a set re-creates the pressure point, a common cushioning failure in a long-wear part. Compression set is characterized per ASTM D3574. [7]

3. One firmness was asked to do two jobs, so it does neither well

A single foam is specified to both cushion the body and hold the part's shape, and it ends up too soft to hold shape or too firm to cushion.

The mechanism is a missing stack: comfort and structure are different jobs that want different firmnesses, and one foam in the middle compromises both, cushioning poorly and holding shape poorly. The fix: build a soft-to-firm stack, a soft microcellular polyurethane comfort layer on the body to cushion and redistribute pressure, and a firm crosslinked polyethylene behind it to hold the shape and resist bottoming, with an EVA or resilient polyurethane transition layer if needed.

The comfort layer offloads the high points; the firm layer gives the structure. State the layers, their firmness, and the order, and H-O laminates the stack and it as one part. A single-firmness pad doing both jobs is the most common cushioning miss.

4. The cushion is too firm and itself creates a pressure point

A pad meant to relieve pressure is too firm, so instead of spreading the load it concentrates it and creates a pressure point of its own, the opposite of its purpose. The mechanism is over-firmness: a foam that does not deform enough under the load cannot conform to the body and spread the pressure across the contact area, so the bony high points still bear concentrated load.

The fix: choose a comfort layer soft enough to deform and conform to the body at the actual load, a microcellular polyurethane redistributes pressure at low stress, and reserve the firm foam for the structural layer behind it, not the contact surface. Size the comfort-layer firmness to the body weight and the site so it conforms without bottoming. State the body weight and any bony prominence to offload so the comfort firmness is right.

Force-deflection is a maker-TDS property characterized per ASTM D3574. [7]

5. A skin-contact basis was never stated, so the wrong grade shipped

A cushioning pad is specified by firmness only, and a quality review later finds it sits directly against skin for prolonged periods with no documented contact basis.

The mechanism is an incomplete spec: a foam that cushions well may not be referenced to the biological-evaluation designation a skin-contact comfort pad needs, and retrofitting documentation after the fact is slow. The fix: state whether the pad is a skin-contact comfort layer or an internal structural layer, the wear duration, and the basis you need (ISO 10993 endpoints, especially -10 sensitization and -23 irritation, a USP Class VI designation, or an FDA contact basis) on the drawing, so H-O references a grade that carries it.

The material maker evaluates the grade; the device maker owns the finished-device file. The structural foam behind the comfort layer has a lighter requirement. ISO 10993-1 sets the contact classification. [1]

Reference

Material reference

Detailed references for the cushioning and structural foam families on this page: the comfort cushioning families (PORON medical microcellular polyurethane, resilient and soft polyurethane foams, and high-density polyurethane for higher loads); and the structural and closed-cell families (firm crosslinked polyethylene and softer EVA), plus the polyurethane-foam family for orientation and an FDA-grade white for a clean contact surface.

Material grades are referenced by designation to ISO 10993 (including -10 and -23 for skin-contact padding), USP Class VI, and an FDA contact basis; the material maker evaluates the grade and the device maker owns the finished-device file.

Foam properties (density, IFD, compression set) are characterized per ASTM D3574; H-O die-cuts, skives, and laminates to drawing. Grade-specific values are per the maker TDS on file, not headline numbers.

PORON medical microcellular polyurethaneIndustry-standard orthotic cushion · low set, pressure redistribution
CompositionMicrocellular polyurethane with controlled, soft force-deflection at low stress and low compression set
RoleThe skin-side comfort top that cushions and redistributes pressure, in an orthotic, brace, or socket
PressureRedistributes load off high-pressure points; conforms to the body at low stress
RecoveryLow compression set; recovers over thousands of cycles so it keeps cushioning
Contact basisGrades referenced to ISO 10993 (incl. -10 / -23) and USP Class VI by designation (maker-evaluated)
Foam propertiesDensity, IFD, and compression set per ASTM D3574; grade-specific values per the maker TDS
Form factorsDie-cut sheet and strip, kiss-cut on liner, laminated as the comfort layer of a soft-to-firm stack
Where it lives in this application: the comfort layer against the body in an orthotic top cover, a brace or socket liner, or a rehab cushion, where controlled, low-set cushioning that redistributes pressure is wanted. The industry-standard orthotic and prosthetic cushioning. Choose it for the comfort layer; put a firm crosslinked polyethylene behind it for structure, and a resilient polyurethane where more energy return is wanted.

PORON medical is a microcellular polyurethane with controlled soft force-deflection, low compression set, and pressure-redistribution behavior, the industry-standard orthotic and prosthetic cushioning. Grades are referenced to ISO 10993 (including the -10 and -23 skin endpoints) and USP Class VI by designation, evaluated by the material maker; force-deflection and compression set are maker-TDS properties per ASTM D3574. H-O converts to drawing and does not certify finished devices.

Resilient polyurethane foam (HyPUR-cel R)Energy return, springs back · brace and rehab cushion
CompositionResilient polyurethane foam with energy return (springs back after load)
RoleCushioning layer for a brace, support, or rehab seating part that cushions and rebounds
ResilienceHigh energy return; springs back rather than staying compressed, for a lively cushion
DurabilityRecovers over repeated use; verify compression set and fatigue on the maker TDS
Contact basisReference the maker documentation for the contact basis where the cushion is skin-adjacent
Foam propertiesDensity, IFD, and resilience per ASTM D3574; grade-specific values per the maker TDS
Form factorsDie-cut sheet and strip; laminated or contoured to the brace or seat
Where it lives in this application: a cushioning layer for a brace, support, or rehab seat where a resilient, lively cushion that springs back is wanted rather than a slow-recovery comfort foam. Choose it for a resilient cushion; use PORON medical for low-set pressure-redistribution comfort and a high-density polyurethane for a heavier load.

A resilient polyurethane foam (HyPUR-cel R) is a high-energy-return cushioning foam commonly used for brace, support, and rehab cushions that cushion and rebound. Density, IFD, and resilience are maker-TDS properties per ASTM D3574; verify compression set and fatigue for a long-wear part. H-O die-cuts and contours the foam to drawing and does not certify finished devices.

Soft polyurethane foam (HyPUR-cel S)Soft, conforming · socket and brace liner, accommodative footbed
CompositionSoft, conforming polyurethane foam that wraps and accommodates
RoleConforming liner for a socket or brace, and an accommodative high-comfort footbed top
ConformabilitySoft; wraps the limb and takes up the gap between the limb and the rigid shell
AccommodationAccommodates pressure-sensitive areas with a soft, deep cushion
Contact basisReference the maker documentation for the contact basis where the liner is skin-contact
Foam propertiesDensity and IFD per ASTM D3574; grade-specific values per the maker TDS
Form factorsDie-cut and contoured to the socket or brace; laminated into the soft-to-firm stack
Where it lives in this application: a soft conforming liner that wraps the limb in a socket or brace and takes up the gap to the rigid shell, and an accommodative high-comfort footbed top. Choose it for a soft, conforming liner; use PORON medical for controlled low-set comfort and a firmer foam for structure.

A soft polyurethane foam (HyPUR-cel S) is a soft, conforming cushioning foam commonly used for socket and brace liners and accommodative footbed tops. Density and IFD are maker-TDS properties per ASTM D3574. H-O die-cuts and contours the foam to drawing and does not certify finished devices.

General-purpose polyurethane foam (HyPUR-cel T)Carries higher load · load-bearing support cushion
CompositionHigh-density polyurethane foam that carries a higher load without bottoming
RoleLoad-bearing cushion or support pad for a heavier load or a higher body weight
LoadHigher density supports more load before bottoming; for a load-bearing seat or pad
DurabilityDense and durable under repeated heavy load; verify fatigue on the maker TDS
Contact basisReference the maker documentation for the contact basis where the pad is skin-adjacent
Foam propertiesDensity, IFD, and compression set per ASTM D3574; grade-specific values per the maker TDS
Form factorsDie-cut and gauged to the load; laminated into a stack as the firm support layer
Where it lives in this application: a load-bearing support cushion or pad for a heavier load or body weight, where a soft comfort foam would bottom out. Choose it for a load-bearing cushion; use a soft microcellular or resilient polyurethane for the comfort layer and a crosslinked polyethylene for a rigid structural base.

A high-density polyurethane foam (HyPUR-cel T) is a dense cushioning foam that carries a higher load without bottoming, commonly used for load-bearing support cushions. Density, IFD, and compression set are maker-TDS properties per ASTM D3574; verify fatigue for a heavy-load part. H-O die-cuts and gauges the foam to drawing and does not certify finished devices.

Crosslinked polyethylene foamFirm, holds shape · orthotic base, structural pad, resists bottoming
CompositionFirm, fine-celled, durable closed-cell crosslinked polyethylene foam
RoleThe firm structural base of a soft-to-firm stack; holds shape and resists bottoming
StructureHolds the orthotic or brace shape under body weight; carries load without collapsing
DurabilityDurable and fine-celled; resists bottoming and holds a or skived contour
Contact basisUsually the internal structural layer; reference maker documentation where contact-adjacent
Foam propertiesDensity and compression per ASTM D3574 / ASTM D1056; grade values per the maker TDS
Form factorsDie-cut and skived to the footbed or brace contour; the firm layer behind the comfort foam
Where it lives in this application: the firm structural layer behind the comfort foam, the base of an orthotic, the shell liner of a brace, or a positioning core, where the part has to hold a shape and resist bottoming under load. Choose it as the firm layer of the soft-to-firm stack; put a microcellular polyurethane comfort top on the body side.

Crosslinked polyethylene foam is a firm, fine-celled, durable closed-cell foam commonly used as the firm structural base of an orthotic or brace, holding shape and resisting bottoming. Density and compression are maker-TDS properties per ASTM D3574 and ASTM D1056. H-O die-cuts and skives the foam to the contour and converts to drawing.

EVA foamSofter, resilient closed-cell · midsole / transition cushion layer
CompositionSofter, resilient closed-cell ethylene-vinyl-acetate (EVA) foam
RoleMidsole or transition cushion layer between the comfort top and the firm base
CushioningSofter and more resilient than crosslinked PE; a mid-firmness cushion in the stack
DurabilityDurable closed-cell foam; available across a firmness range by grade
Contact basisReference the maker documentation for the contact basis where contact-adjacent
Foam propertiesDensity and compression per ASTM D3574 / ASTM D1056; grade values per the maker TDS
Form factorsDie-cut and skived to the insole or part; the transition layer of a soft-to-firm stack
Where it lives in this application: a midsole or transition cushion layer in an insole or pad, sitting between the soft comfort top and the firm base, or as a softer cushion surface. Choose it for a mid-firmness cushion layer; use a microcellular polyurethane for the comfort top and a crosslinked polyethylene for the firm base.

EVA foam is a softer, resilient closed-cell foam commonly used as a midsole or transition cushion layer in an orthotic or pad. It is available across a firmness range by grade; density and compression are maker-TDS properties per ASTM D3574 and ASTM D1056. H-O die-cuts and skives the foam to the part and converts to drawing.

View all EVA foam → Browse the materials catalog →
Polyurethane foam (family)Broad PU cushioning range · orientation across soft to firm
CompositionThe broad polyurethane foam family, spanning soft to firm cushioning grades
RoleOrientation across the polyurethane cushioning range when narrowing a grade
RangeSoft conforming through firm load-bearing, including microcellular and resilient types
SelectionNarrow to PORON medical, HyPUR-cel R / S / T, or a specific grade for the job
Contact basisReferenced by designation at the material level for the specific grade chosen
Foam propertiesDensity, IFD, and compression set per ASTM D3574 for the specific grade
Form factorsDie-cut, skived, and laminated to drawing once the grade is chosen
Where it lives in this application: the orientation family when you are narrowing a polyurethane cushioning grade across the soft-to-firm range. Choose a specific grade (PORON medical for low-set comfort, HyPUR-cel R / S / T for resilient, soft, or high-density) for the job; this family is the starting point.

The polyurethane foam family spans the soft-to-firm cushioning range used in orthotics, prosthetics, and rehab, from microcellular and soft conforming grades to resilient and high-density load-bearing grades. Properties are maker-TDS properties per ASTM D3574 for the specific grade. H-O converts the chosen grade to drawing.

FDA-grade white elastomerClean white surface · cushion or contact surface, FDA composition basis
CompositionWhite FDA-grade elastomer; the composition meets a fluid- or food-contact basis
RoleA clean white contact surface or cover layer on a cushion or pad
Contact basisFDA-grade composition (contact basis), not a device clearance; clean appearance
ColorWhite, for a clean appearance and a wipeable contact surface
DurometerPer TDS on file (reported per ASTM D2240 where applicable)
SubstratesLaminated to or as a cover over a cushioning foam
Form factorsDie-cut to the outline; gauge sized to the cover or surface need
Where it lives in this application: a clean white contact surface or cover layer over a cushioning foam, where a wipeable surface and an FDA composition basis are wanted. Choose it for a clean contact surface; use the cushioning foams for the cushioning itself.

FDA-grade white elastomer is commonly used for a clean white contact surface or cover over a cushioning foam. The FDA-grade designation describes the composition and contact basis, not a device clearance. Durometer is per the maker TDS. H-O die-cuts and laminates it to drawing and does not certify finished devices.

Engineering questions

Orthotics, prosthetics & rehab FAQ

The questions orthotic, prosthetic, and rehab-equipment designers ask when specifying a cushioning or pressure-redistribution foam. Answers are cautious and at the material level; the device maker owns the finished-device biocompatibility and regulatory file.

12 questions · click a question to expand its answer

Which foam is the standard orthotic cushioning material?

PORON medical, a microcellular polyurethane, is the industry-standard orthotic and prosthetic cushioning material. It gives controlled, soft force-deflection at low stress, so it cushions and conforms to the body, and it has low compression set, so it recovers over thousands of steps a day instead of flattening. That combination, cushioning plus recovery, is what makes it the default comfort layer in an orthotic top cover, a brace or socket liner, and a rehab cushion.

It is used as the comfort layer of a soft-to-firm stack, on the body side, with a firm crosslinked polyethylene behind it for structure. Where more energy return or a different firmness is wanted, a resilient or soft polyurethane foam (HyPUR-cel R or S) is the alternative, and for a heavier load a high-density polyurethane carries more before bottoming. Force-deflection and compression set are characterized per ASTM D3574; grade-specific values are per the maker TDS.

The grade is referenced to ISO 10993 and USP Class VI by designation.

Why is a soft-to-firm stack better than a single foam?

Because comfort and structure are different jobs that want different firmnesses, and one foam in the middle compromises both. A soft foam cushions and redistributes pressure but, on its own, bottoms out under load and does not hold the part's shape; a firm foam holds shape and resists bottoming but does not cushion.

The reliable answer is a soft-to-firm stack: a soft microcellular polyurethane comfort layer on the body to cushion and offload the high points, and a firm crosslinked polyethylene behind it to hold the shape, carry the load, and stop the soft layer bottoming out, with an EVA or resilient polyurethane transition layer if needed.

The comfort layer feels right; the firm layer gives the structure. H-O laminates the stack and it as one part. Specifying a single firmness to do both jobs is the most common cushioning miss, producing a part that either bottoms out or does not cushion. State the layers, their firmness, and the order body outward.

How do I keep the cushion from flattening over time?

Choose a cushioning grade with low compression set and size it for the wear. A cushion flattens because of compression set: a foam not chosen for low set gradually deforms permanently under the repeated load (thousands of steps a day in an insole, constant pressure in a brace), so it loses thickness, stops cushioning, and the pressure point it was meant to relieve returns.

A microcellular polyurethane such as PORON medical is selected for orthotic and bracing comfort precisely because it has low compression set and recovers over the wear; for a heavier or more repeated load, a resilient or high-density polyurethane lasts better. State the wear (steps per day, hours of wear, cycles of use) and the expected life so the grade recovers over it, and consider the soft-to-firm stack so the firm layer carries the structural load and the comfort layer only does the cushioning.

Compression set and fatigue are maker-TDS properties characterized per ASTM D3574; this page frames them qualitatively and defers grade-specific limits to the TDS on file.

My cushion bottoms out under body weight. What do I change?

Bottoming out means the foam is too soft or too thin for the load: under body weight it compresses to its limit, so it no longer deforms to spread the pressure and the user feels the hard surface through it. The fix is to match the firmness and the thickness to the load.

Step up to a firmer or denser foam, or build a soft-to-firm stack with a firm crosslinked polyethylene base behind the soft comfort layer so the part deforms to cushion without reaching its limit; for a heavier body weight or a load-bearing pad, a high-density polyurethane carries the load.

Increasing the thickness of the comfort layer helps only up to a point, the right answer is usually the stack, where the firm layer carries the structural load and the comfort layer does the cushioning. State the body weight and the load at the site so the firmness, density, and gauge are sized correctly. Force-deflection and density are characterized per ASTM D3574; grade values are per the TDS on file.

Can a foam that is too firm cause a pressure sore?

Yes, an over-firm cushion can concentrate pressure rather than relieve it, the opposite of its purpose. The job of a cushioning foam is to deform under load and spread the pressure across the contact area, so the bony high points carry less concentrated load. A foam that is too firm does not deform enough to conform to the body, so the high points still bear the concentrated load and the part can create a pressure point of its own.

The fix is to choose a comfort layer soft enough to deform and conform at the actual load, a microcellular polyurethane redistributes pressure at low stress, and reserve the firm foam for the structural layer behind it, not the contact surface. Size the comfort-layer firmness to the body weight and the site so it conforms without bottoming, which is the balance the soft-to-firm stack is designed to strike.

State the body weight and any bony prominence to offload so the comfort firmness is right. Force-deflection is a maker-TDS property per ASTM D3574. The clinical assessment of pressure and skin integrity belongs to the device maker and the clinician.

How does H-O document the biocompatibility basis for body-contact padding?

H-O references material grades by designation and assembles documentation aligned to your requirements. For a skin-contact comfort pad worn for prolonged periods, state that it is skin-contact, the wear duration, and the basis you need, ISO 10993 endpoints (especially -10 sensitization and -23 irritation, with -5 cytotoxicity as the baseline), a USP Class VI designation, or an FDA contact basis, and H-O sources a grade whose maker evaluates it against those frameworks and provides the material TDS, certificate of conformance, and lot traceability.

The structural foam behind the comfort layer has a lighter contact requirement. The important distinction is who owns what: the material maker evaluates the grade at the material level, and the device maker owns the finished-device biocompatibility and regulatory file. H-O is an ISO 9001:2015 certified converter; it does not independently certify materials and does not certify finished devices, and it does not claim an ISO 13485 certification, an FDA device registration, or a cleanroom certification.

Customer-specified compliance packages are assembled on request.

Can H-O contour or skive a footbed or socket liner to a varying thickness?

Yes. A flat pad is to its outline, but a footbed, an accommodative orthotic, or a socket liner often needs a varying thickness, thicker where more cushioning or offloading is wanted, thinner elsewhere, and H-O skives or profiles the foam to that contour. H-O also laminates the soft-to-firm stack and it as one piece, and adds a pressure-sensitive adhesive on one face, kiss-cut on a release liner, where the pad mounts to a shell or footbed.

State the outline, the thickness map or contour, the layers and their order, whether the part carries an adhesive and on which face, and how it ships. Where the comfort layer is skin-contact, name the contact basis so any adhesive near it is referenced too. Die-cut, skive, lamination, and kiss-cut-on-liner are the standard H-O converting operations that turn the cushioning foams into a finished, contoured orthotic or liner part to your drawing.

What is the difference between crosslinked polyethylene and EVA for padding?

They sit at different firmnesses in the stack. A crosslinked polyethylene foam is firm, fine-celled, and durable, so it is the structural base layer: it holds the orthotic or brace shape, carries the load, and resists bottoming, but it is not the soft cushion. An EVA foam is softer and more resilient, so it is a midsole or transition cushion layer, sitting between the soft comfort top and the firm base, or a softer cushion surface; it is available across a firmness range by grade.

In a typical soft-to-firm orthotic, a microcellular polyurethane comfort top sits on the foot, an EVA transition layer cushions, and a crosslinked polyethylene base gives the structure. So crosslinked polyethylene is chosen for firmness and shape retention, EVA for a softer mid cushion. Both are closed-cell, durable foams characterized per ASTM D3574 and ASTM D1056. State the role each layer plays so the right firmness is chosen for each, and H-O die-cuts and skives them into the stack.

Which foam should I use for a load-bearing rehab or seating cushion?

For a load-bearing rehab or seating cushion, the firmness and density have to carry the load without bottoming, while still cushioning. A high-density polyurethane foam (HyPUR-cel T) carries a higher load before bottoming, which suits a support cushion or a load-bearing pad; a resilient polyurethane foam (HyPUR-cel R) gives a lively cushion with energy return for a seat that should rebound; and a firm crosslinked polyethylene gives a structural base or positioning core under the cushion.

Often the answer is a stack: a resilient or comfort cushion on top for feel, and a high-density or firm base to carry the load. The deciding questions are the load and body weight, the durability the repeated use demands, and whether the surface is cleaned. State those, and H-O recommends the grade and the stack and the cushion to the equipment.

Force-deflection, density, and fatigue are maker-TDS properties characterized per ASTM D3574; grade values are per the TDS on file.

Does H-O make finished orthotics, prosthetics, or braces?

No. H-O Products is a precision converter: it makes the cushioning, pressure-redistribution, and liner foam parts to your drawing from cushioning material grades commonly used against the body, under an ISO 9001:2015 quality management system. H-O is an ISO 9001:2015 certified organization; that certification governs the converting process, not a device clearance. H-O does not make finished orthotics, prosthetics, braces, or rehab devices and does not claim an ISO 13485 certification, an FDA device registration or clearance, or a cleanroom certification.

Material grades are referenced by designation to ISO 10993 (especially -10 and -23 for skin-contact padding), USP Class VI, and FDA contact frameworks at the material level, where the material maker performs the evaluation. The finished-device biocompatibility, the clinical fit and pressure assessment, and the regulatory file belong to the device maker and the clinician. H-O supplies the converted foam parts, the material documentation, and lot traceability aligned to your requirements.

What do I send H-O to get an orthotic or rehab padding quote?

Send the orthotic, brace, or equipment drawing or a sample, the part you need, and the key facts: the body site and job (orthotic or insole, brace or support or socket, or rehab or therapy equipment), the load and body weight, the firmness and whether you want a soft-to-firm stack, the durability the wear demands (steps per day, hours, cycles), and the contact basis (whether the pad is skin-contact, the wear duration, and the ISO 10993 endpoints, USP Class VI designation, or FDA basis you need).

Add the outline and any contour or skive, the layers and their order, any adhesive side, and the prototype and annual volume. With that, engineering returns a material family and a soft-to-firm direction, a converted-part approach (including any lamination and contouring), prototype lead time, and the documentation that can be aligned to your requirements. The quote form below has fields for each of these.

Samples typically ship in 3 to 5 business days; standard production in about 2 weeks.

Are the same foams used for prosthetic liners and orthotic insoles?

They overlap heavily, because the underlying job is the same: cushion the body and redistribute pressure. A microcellular polyurethane such as PORON medical is the comfort layer in both an orthotic insole top and a prosthetic socket or brace liner, chosen for low-set cushioning that offloads high-pressure points and recovers over the wear.

A soft conforming polyurethane (HyPUR-cel S) is favored for a socket or brace liner that has to wrap the limb and take up the gap to the rigid shell, while a firm crosslinked polyethylene is the structural base in an orthotic and a shell liner in a brace.

The differences are in the contour and the load: a prosthetic socket liner is contoured to the limb and may carry more concentrated load, an orthotic insole is contoured to the footbed and sees thousands of steps a day. So the families are shared, but the grade, the firmness, the contour, and the soft-to-firm stack are tuned to the site.

State the site, the contour, and the load, and H-O recommends and converts the right grade and stack. Foam properties are characterized per ASTM D3574.

Definitions

Glossary: terms used on this page

Quick reference for the cushioning, pressure-redistribution, foam, and biocompatibility terminology used throughout. Each entry links to the relevant standard or designation where applicable.

Pressure redistribution / offloading

Spreading load off high-pressure points (a bony prominence, a metatarsal head) across a larger contact area so no one spot bears concentrated pressure. A cushioning foam redistributes pressure by deforming under load to conform to the body. It is the core job of orthotic, bracing, and rehab padding; a foam too firm to deform or too soft and bottomed out fails to redistribute.

Soft-to-firm stack

A laminated padding construction with a soft comfort foam on the body side and a firm foam behind it. The soft layer (microcellular polyurethane) cushions and redistributes pressure; the firm layer (crosslinked polyethylene) holds shape, carries load, and stops the soft layer bottoming out. It does what a single firmness cannot, and is the standard build for orthotics and braces. H-O laminates and it as one part.

Bottoming out

When a cushioning foam compresses fully under load and reaches its limit, so it can no longer deform to spread pressure and the user feels the hard surface through it. A foam too soft or too thin for the load bottoms out. The fix is a firmer or denser foam, more thickness, or a soft-to-firm stack so the firm layer carries the load.

Compression set

The permanent deformation a foam retains after being held compressed. A cushioning foam with high compression set gradually loses its thickness and recovery under the repeated load, so it flattens, stops cushioning, and the pressure point it relieved returns. A low-compression-set grade (such as a microcellular polyurethane) is central to a durable long-wear cushion. Characterized per ASTM D3574.

Microcellular polyurethane (PORON)

A polyurethane foam with a very fine, uniform cell structure that gives controlled, soft force-deflection at low stress and low compression set. PORON medical is the industry-standard orthotic and prosthetic cushioning, used as the comfort layer because it cushions, redistributes pressure, and recovers over thousands of cycles without flattening.

Force-deflection / IFD (firmness)

How much a foam deflects under a given load, the measure of its firmness, reported for cellular urethane foam by indentation force deflection (IFD) or compression force deflection (CFD) per ASTM D3574. A lower force-deflection is softer; a higher one is firmer. Matching the firmness to the body site and the load is central to a cushion that redistributes pressure without bottoming.

Crosslinked polyethylene foam

A firm, fine-celled, durable closed-cell polyethylene foam used as the structural base of an orthotic or brace. It holds the part's shape under body weight, carries load, and resists bottoming, but it is not the soft cushion. It is the firm layer of the soft-to-firm stack, behind a microcellular polyurethane comfort top.

EVA foam

A softer, resilient closed-cell ethylene-vinyl-acetate foam, available across a firmness range by grade. In padding it is the midsole or transition cushion layer, sitting between the soft comfort top and the firm base, or a softer cushion surface. It cushions more than crosslinked polyethylene but holds shape less.

ISO 10993 (biological evaluation, by designation)

The international standard family for the biological evaluation of medical devices within a risk-management process. For a skin-contact comfort pad the key endpoints are -10 (sensitization) and -23 (irritation), with -5 (cytotoxicity) as the baseline. On this page a grade is referenced to ISO 10993 by designation; the material maker evaluates the grade and the device maker owns the finished-device evaluation.

USP Class VI

The strictest of the USP plastics classes, based on the in-vivo biological-reactivity tests of USP <88> (systemic toxicity, intracutaneous, and a muscle-implant screen). A USP Class VI designation is a material-level screen the material maker performs; it is a useful reference point for a material grade but is not a finished-device clearance. On this page it is cited by designation only.

FDA-grade (composition basis)

A description of a material's composition and contact basis (for example a material meeting an FDA 21 CFR contact regulation), not a device clearance. An FDA-grade material is made from ingredients that meet a relevant FDA contact regulation; it does not by itself mean the finished device is FDA-cleared. Composition basis at the material level versus device clearance at the device level.

Converter (die-cut)

A manufacturer that takes maker stock (sheet, slab, roll) and converts it to a finished part by die-cutting, kiss-cutting, skiving, laminating, slitting, and kitting, to a customer's drawing. H-O is a precision converter; it die-cuts, skives, and laminates the cushioning foams, and it does not make finished orthotics, prosthetics, or braces. It supplies the converted foam parts and the material documentation, under an ISO 9001:2015 quality management system.

Last updated · Reviewed by H-O Products engineering (ISO 9001:2015 certified converter, Winsted, CT).

Citations

Standards, designations & technical references

The standards, designations, and material references cited throughout this page. Standards editions current as of June 2026; verify against the publishing body before final spec. Material grades are referenced to the biological-evaluation frameworks by designation, where the material maker performs the evaluation; H-O is an ISO 9001:2015 certified converter and does not independently certify materials or finished devices. No competitor company names appear on this page; material makers are named in this References block only.

ISO 10993-1

Biological evaluation of medical devices, Part 1: Evaluation and testing within a risk-management process. Classifies a part by contact type (surface / external-communicating / implant) and duration, which sets which biological endpoints apply. A skin-contact comfort pad is surface contact. Referenced by designation at the material level. iso.org (ISO 10993-1)

ISO 10993-5

Biological evaluation of medical devices, Part 5: Tests for in vitro cytotoxicity. The baseline screen for a skin-contact material, evaluated against by the material maker. iso.org (ISO 10993-5)

ISO 10993-10

Biological evaluation of medical devices, Part 10: Tests for skin sensitization. The key skin-contact endpoint for a comfort pad worn against the body. Referenced by designation at the material level. iso.org (ISO 10993-10)

USP Class VI / USP <88>

Biological Reactivity Tests, In Vivo (USP <88>), the basis of the USP Class VI plastics designation (the strictest class). A material-level reactivity screen the material maker performs; cited by designation, not as a device clearance. usp.org

FDA 21 CFR 177.2600

Rubber articles intended for repeated use, a composition basis for an FDA-grade material. Describes permissible ingredients for repeated contact; it is a material composition basis, not a medical-device clearance. ecfr.gov (21 CFR 177)

ASTM D3574

Standard Test Methods for Flexible Cellular Materials, Slab, Bonded, and Molded Urethane Foams. The reference for the density, indentation force deflection (IFD/firmness), compression set, tensile, and tear of the cushioning polyurethane foams, reported on the maker TDS. astm.org/d3574

ASTM D1056

Standard Specification for Flexible Cellular Materials, Sponge or Expanded Rubber. The reference for cellular properties (compression, density) used to characterize the closed-cell crosslinked polyethylene and EVA structural and cushion foams. astm.org/d1056

ASTM D2240

Standard Test Method for Rubber Property, Durometer Hardness. Reports the hardness where a firmer cover or contact-surface material (such as an FDA-grade elastomer) is specified by durometer. astm.org/d2240

ISO 9001:2015

Quality management systems, Requirements. The standard H-O's converting quality management system is certified to. It governs the converting process and documentation, not a medical-device clearance. iso.org (ISO 9001:2015)

Rogers PORON medical polyurethane (maker TDS)

Supplier technical data for PORON medical microcellular polyurethane, including the force-deflection, compression set, and biological-designation references that make it the industry-standard orthotic cushion. Material-maker data, cited here as a reference; H-O converts the stock to drawing. rogerscorp.com

Polyurethane, polyethylene & EVA foam makers (maker TDS)

Supplier technical data for the HyPUR-cel resilient, soft, and high-density polyurethane foams, crosslinked polyethylene foam, and EVA foam used in the cushioning and structural layers, including density, IFD, and compression-set references. Material-maker data, cited here as a reference; H-O die-cuts, skives, and laminates the foams to drawing. foam supplier TDS

Updated . Standards editions, designations, and links current at publication; verify against the publishing body before final spec. Material designations are referenced at the material level; lot-specific documentation aligned to your requirements is available on request.

Before you request a quote

What to send H-O for an orthotic, prosthetic, or rehab padding quote

The faster H-O can recommend a material and converted-part approach, the more of this you can include up front. None of it is required to start, the quote form below walks you through it.

The body site and the part

The body site and job (orthotic or insole, brace or support or socket, or rehab or therapy equipment); the orthotic, brace, or equipment drawing (DXF, STEP, or PDF) or a sample, or a foot or limb profile; the outline and any contour or skive (a thickness map for a footbed or liner); and the layers and their order plus any adhesive side and which face.

The load and the basis

The load and body weight, the firmness and whether you want a soft-to-firm stack, and the durability the wear demands (steps per day, hours of wear, cycles of use); the contact basis (whether the pad is skin-contact, the wear duration, and the ISO 10993 endpoints, especially -10 and -23, a USP Class VI designation, or an FDA contact basis); and the prototype and annual volume.

Quote request

Get an orthotics, prosthetics & rehab quote

Send a drawing, BOM, or spec sheet. We typically respond within one business day with a material-family recommendation and a soft-to-firm direction, prototype lead time, and TDS and designation verification against your body site, load, durability, and contact basis.

Contact
Company address
Your application
Part & quantity
Typical response in one business day. Samples typically 3–5 business days; production in about 2 weeks.

Material data & designations. All firmness, density, compression-set, and durometer figures on this page are taken from the source material maker's technical data sheets and the cited standards and designations.

Grade-specific force-deflection (IFD/CFD), density, compression-set, and durometer values are reported on the TDS on file for each grade; this page frames them qualitatively and references the test methods and designations (ISO 10993, especially -10 and -23, USP Class VI, FDA contact basis, ASTM D3574, ASTM D1056, ASTM D2240) rather than quoting numbers that vary by grade, load, and body site.

Material grades are referenced to the biological-evaluation frameworks at the material level, where the material maker performs the evaluation; the device maker and the clinician own the finished-device biocompatibility, the clinical fit and pressure assessment, and the regulatory file. H-O is an ISO 9001:2015 certified organization; it does not claim an ISO 13485 certification, an FDA device registration or clearance, or a cleanroom certification, and it does not certify finished devices.

Nothing on this page is a clinical or therapeutic claim.

Conversion scope. H-O die-cuts, skives, and converts sheet, slab, and roll stock to drawing in Winsted, Connecticut: die-cut and kiss-cut-on-liner cushioning pads and liners, laminated soft-to-firm stacks, skived and contoured footbeds and liners, slit rolls, and kits, with material traceability and lot-code documentation.

H-O does not mold or extrude foams in-house and does not make finished orthotics, prosthetics, or braces; molded or extruded profiles are coordinated through a partner network. Lead-time and minimum-run details are on the process strip and in the quote form above.

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