Device Explorer · FDA GUDID · GMDN 42501

Heel protector

A device that is designed to be worn over the foot to provide a cushion to protect the heel from friction against surfaces and knocks against objects; the toes will protrude and not be protected. It is typically made from soft padded materials and is held in p

US‑registered devices250in commercial distribution
Companies7labelers on GUDID
Single‑use79%of device records
Sterile1%labelled sterile
Prescription27%Rx‑only share
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Share of device records

Primo Inc8032%
Deroyal Industries, Inc.6827%
Ehob Inc5120%
Frontier Therapeutics Inc3112%
Brownmed, Inc.166%
E.M. Adams, Inc.31%
Vive Health Llc10%

Top labelers

CompanyDevicesShare
Primo Inc8032%
Deroyal Industries, Inc.6827%
Ehob Inc5120%
Frontier Therapeutics Inc3112%
Brownmed, Inc.166%
E.M. Adams, Inc.31%
Vive Health Llc10%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Repose Sole Protector and Pump (10 Singles)Repose Footprotector PLUS (Pair) and Pump - 10 SRepose Footprotectors (Pair) and Pump (10 SingleRepose Single Footprotector and Pump 10 SinglesRepose Long Footprotectors (pair) and Pump - 10 Repose 1 Long Footprotector and Pump (10 SinglesRepose Sole Protector x 1 with Small PumpRepose Flex - Standard 1 Flex and PumpRepose Flex - Small 1 Flex and PumpRepose Flex - Extra Small 1 Flex and PumpRepose Extra Small Footprotector Plus (Single) aRepose Extra Small Footprotectors (Pair) and PumRepose Extra Small Footprotector Plus (Bulk PackRepose Small Footprotectors Plus (Single) and PuRepose Small Footprotectors Plus (Pair) and PumpRepose Small Footprotector Plus (Bulk Pack 10) w

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 Pressure170
FMPProtector, skin pressure68
ITWJoint, Ankle, External Brace17

GMDN & GCC registration

  • GMDN code 42501 · non‑implantable
  • Single‑use 79% · sterile 1% · Rx‑only 27% · OTC 7%
  • 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 heel protector products are registered in the US?

250 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Heel protector", from 7 companies. The largest labeler is Primo Inc with 32% of records.

Which FDA product codes apply?

FMP (Protector, Skin Pressure), FMP (Protector, skin pressure), ITW (Joint, Ankle, External Brace)

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.

How do I get quotes?

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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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