Consulting Wallah › Device Explorer › Orthoses & supports › Ankle/foot orthosis
Device Explorer · FDA GUDID · GMDN 36206

Ankle/foot orthosis

A prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle an

US‑registered devices3,146in commercial distribution
Companies46labelers on GUDID
Single‑use46%of device records
Sterile2%labelled sterile
Prescription19%Rx‑only share
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Share of device records

Deroyal Industries, Inc.52717%
Md Orthopaedics, Inc.44214%
Bird & Cronin, Llc42313%
Thrive Orthopedics Llc2739%
Medi Manufacturing, Inc.1916%
Vive Health Llc1495%
Djo, Llc1485%
Elite Orthopaedics, Inc.1344%

Top labelers

CompanyDevicesShare
Deroyal Industries, Inc.52717%
Md Orthopaedics, Inc.44214%
Bird & Cronin, Llc42313%
Thrive Orthopedics Llc2739%
Medi Manufacturing, Inc.1916%
Vive Health Llc1495%
Djo, Llc1485%
Elite Orthopaedics, Inc.1344%
Medical Specialties Incorporated1194%
Trulife Limited953%
Neotech Care Inc.823%
Darco International, Inc.662%

Company = labeler of record on GUDID. 46 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HuaKangTairuibosiELITE BRITEDR -HOSCofoeM-Brace AirDARCO® Body Armor® EmbraceTrulifePace"TM ""Rehabilitimed"" GS-2 XL Comfort""TM ""Rehabilitimed"" GS-2 L Comfort""TM ""Rehabilitimed"" GS-2 M Comfort""TM ""Rehabilitimed"" GS-2 S Comfort""TM ""Rehabilitimed"" DS-1 UNI Comfort""TM ""Rehabilitimed"" RS-B12 XL Comfort""TM ""Rehabilitimed"" RS-B12 L Comfort"

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

FDA product codes

CodeNameDevices
ITWJoint, Ankle, External Brace1,055
ITWJOINT, ANKLE, EXTERNAL BRACE892
KNPOrthosis, Corrective Shoe441
IQIOrthosis, Limb Brace372
IQIORTHOSIS, LIMB BRACE130
NOCSplint, extremity, non-inflatable, external, non-sterile72

GMDN & GCC registration

  • GMDN code 36206 · non‑implantable
  • Single‑use 46% · sterile 2% · Rx‑only 19% · OTC 33%
  • 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.

No closely related category with 50+ devices.

How many ankle/foot orthosis products are registered in the US?

3,146 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ankle/foot orthosis", from 46 companies. The largest labeler is Deroyal Industries, Inc. with 17% of records.

Which FDA product codes apply?

ITW (Joint, Ankle, External Brace), ITW (JOINT, ANKLE, EXTERNAL BRACE), KNP (Orthosis, Corrective Shoe), IQI (Orthosis, Limb 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?

Add ankle/foot orthosis to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

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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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