Device Explorer · FDA GUDID · GMDN 41458

Wrist orthosis

A prefabricated (non-customized), non-rigid, externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the wrist. This is a reusable device.

US‑registered devices541in commercial distribution
Companies21labelers on GUDID
Single‑use27%of device records
Sterile7%labelled sterile
Prescription1%Rx‑only share
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Share of device records

Medical Specialties Incorporated18033%
Medi Manufacturing, Inc.10519%
Djo, Llc7013%
Grainger International, Inc.336%
Nea International B.V.326%
Tetra Medical Supply Corp.295%
Alimed, Inc.285%
Vive Health Llc122%

Top labelers

CompanyDevicesShare
Medical Specialties Incorporated18033%
Medi Manufacturing, Inc.10519%
Djo, Llc7013%
Grainger International, Inc.336%
Nea International B.V.326%
Tetra Medical Supply Corp.295%
Alimed, Inc.285%
Vive Health Llc122%
Brownmed, Inc.92%
Walgreen Co.92%
Bort Gmbh81%
Silipos Holding Llc71%

Company = labeler of record on GUDID. 21 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CofoeMEDIBort GmbHDONJOY PERFORMANCETrendVIVEViveCMC-X Lacer Thumb StabilizerCMC-X Thumb StabilizerCMC Thumb SupportTRIPOD WRIST LACER IIWrist LacerTFCC Wrist WrapMotion Manager Wrist SupportGelFlex Wrist SupportCompressor Wrist Support

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 Components244
IQIORTHOSIS, LIMB BRACE221
IMSSupport, Head And Trunk, Wheelchair33
ILHSPLINT, HAND, AND COMPONENTS29
IQIOrthosis, Limb Brace7
FMPProtector, Skin Pressure7

GMDN & GCC registration

  • GMDN code 41458 · non‑implantable
  • Single‑use 27% · sterile 7% · Rx‑only 1% · OTC 46%
  • 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 orthosis products are registered in the US?

541 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Wrist orthosis", from 21 companies. The largest labeler is Medical Specialties Incorporated with 33% of records.

Which FDA product codes apply?

ILH (Splint, Hand, And Components), IQI (ORTHOSIS, LIMB BRACE), IMS (Support, Head And Trunk, Wheelchair), ILH (SPLINT, HAND, AND COMPONENTS)

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 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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