Consulting Wallah › Device Explorer › Orthoses & supports › Wrist/hand orthosis
Device Explorer · FDA GUDID · GMDN 41459

Wrist/hand orthosis

An externally applied orthopaedic appliance or apparatus designed to support, correct, or improve function of the wrist and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. This is a reusable device.

US‑registered devices456in commercial distribution
Companies14labelers on GUDID
Single‑use18%of device records
Sterile0%labelled sterile
Prescription3%Rx‑only share
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Share of device records

Blake Manufacturing, Inc.16536%
Pantymed S.A.6013%
Macu4 Gmbh5412%
Comfy Health Group Co., Ltd.5211%
Darco (Europe) Gmbh327%
Darco International, Inc.307%
Vive Health Llc133%
Bird & Cronin, Llc133%

Top labelers

CompanyDevicesShare
Blake Manufacturing, Inc.16536%
Pantymed S.A.6013%
Macu4 Gmbh5412%
Comfy Health Group Co., Ltd.5211%
Darco (Europe) Gmbh327%
Darco International, Inc.307%
Vive Health Llc133%
Bird & Cronin, Llc133%
Medical Specialties Incorporated102%
Indaco Srl82%
Comfytopia, Inc.82%
Orthofix Us Llc61%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

M-Brace Air"TM ""Rehabilitimed"" TUTOR-6K-VU UNI Right""TM ""Rehabilitimed"" TUTOR-6K-VU UNI Left"ComfyhealthComfyHealthLynk Hold Lock O-2Lumo Hold O-2Lynk Cover, LRGLynk Cover, MEDLynk Cover, SMLLynk Cuff STD-SMLLynk Cuff STD-MEDLynk Cuff STD-LRGLynk Cuff SHT-extra SMLLynk Cuff SHT-LRGLynk Cuff SHT-MED

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

FDA product codes

CodeNameDevices
ILHSplint, Hand, And Components205
IQIOrthosis, Limb Brace68
ILHSPLINT, HAND, AND COMPONENTS62
MRIOrthosis, Truncal/Orthosis, Limb60
ILTAdaptor, Recreational54
IQIORTHOSIS, LIMB BRACE6

GMDN & GCC registration

  • GMDN code 41459 · non‑implantable
  • Single‑use 18% · sterile 0% · Rx‑only 3% · OTC 41%
  • 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 wrist/hand orthosis products are registered in the US?

456 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Wrist/hand orthosis", from 14 companies. The largest labeler is Blake Manufacturing, Inc. with 36% of records.

Which FDA product codes apply?

ILH (Splint, Hand, And Components), IQI (Orthosis, Limb Brace), ILH (SPLINT, HAND, AND COMPONENTS), MRI (Orthosis, Truncal/Orthosis, Limb)

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 wrist/hand 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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