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Device Explorer · FDA GUDID · GMDN 36295

Foot friction/impact protector

A device designed to be worn over/on the foot, often while wearing shoes, to provide a cushion to protect the whole foot or parts of the foot (e.g., toes, metatarsal heads, heel) from friction against surfaces or knocks against objects, to relieve pain during

US‑registered devices257in commercial distribution
Companies12labelers on GUDID
Single‑use7%of device records
Sterile0%labelled sterile
Prescription3%Rx‑only share
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Share of device records

Silipos Holding Llc19475%
Vive Health Llc2610%
Deroyal Industries, Inc.73%
Mizuho Orthopedic Systems, Inc.62%
Darco (Europe) Gmbh62%
Meijer, Inc.52%
Darco International, Inc.42%
Ehob Inc31%

Top labelers

CompanyDevicesShare
Silipos Holding Llc19475%
Vive Health Llc2610%
Deroyal Industries, Inc.73%
Mizuho Orthopedic Systems, Inc.62%
Darco (Europe) Gmbh62%
Meijer, Inc.52%
Darco International, Inc.42%
Ehob Inc31%
Mölnlycke Health Care Ab21%
Prim S.A.21%
Bird & Cronin, Llc10%
Posey Products, Llc10%

Company = labeler of record on GUDID. 12 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Mölnlycke® Z-Flex™ Fluidized Heel BootViveSoleOrtho Boot LinerBOOT, ORTHO, PAIRHEEL PROTECTORS, SET OF 2ORTHO BOOT W/LINER, PER PAIRLINERS, BOOT, ORTHO, 1/PRTLC CRADLE BOOTVIVEViveVivesoleDeRoyalMEIJERHalf Coated Tubing 26mm Wide x 25Cm LongFull Coated Tubing 26mm Wide x 25Cm Long"Digistrip Z, 3"", Small"

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
FMPProtector, Skin Pressure204
FMPProtector, skin pressure69
OHIOrthosis, Foot Drop16
KYSInsoles, Medical14
ITWJoint, Ankle, External Brace3
CCXSupport, Patient Position2

GMDN & GCC registration

  • GMDN code 36295 · non‑implantable
  • Single‑use 7% · sterile 0% · Rx‑only 3% · OTC 11%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many foot friction/impact protector products are registered in the US?

257 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Foot friction/impact protector", from 12 companies. The largest labeler is Silipos Holding Llc with 75% of records.

Which FDA product codes apply?

FMP (Protector, Skin Pressure), FMP (Protector, skin pressure), OHI (Orthosis, Foot Drop), KYS (Insoles, Medical)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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