Consulting Wallah › Device Explorer › Orthoses & supports › Lower-limb orthosis ankle/foot component, mechanic
Device Explorer · FDA GUDID · GMDN 66444

Lower-limb orthosis ankle/foot component, mechanical-resistance

A non-powered prefabricated (non-customized) component of an externally applied and wearable lower-limb appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct deformities/injuries (e.g., para

US‑registered devices54in commercial distribution
Companies1labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
ShareLinkedIn

Share of device records

Darco International, Inc.54100%

Top labelers

CompanyDevicesShare
Darco International, Inc.54100%

Company = labeler of record on GUDID. 1 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DARCO® FXPro Walker LinerDARCO® FX Pro™ WalkerHED-LOC™DARCO® Body Armor® Walker linerDARCO® Body Armor® Walker IIDARCO® Body Armor® WalkerBUCKS TRACTION w/LINERHealth Design Ankle Leg WalkerHealth Design Tall Leg Walker

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

FDA product codes

CodeNameDevices
NOCSplint, extremity, non-inflatable, external, non-sterile56
HSPSPLINT, TRACTION1

GMDN & GCC registration

  • GMDN code 66444 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 0% · OTC 0%
  • 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 lower-limb orthosis ankle/foot component, mechanical-resistance products are registered in the US?

54 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Lower-limb orthosis ankle/foot component, mechanical-resistance", from 1 companies. The largest labeler is Darco International, Inc. with 100% of records.

Which FDA product codes apply?

NOC (Splint, extremity, non-inflatable, external, non-sterile), HSP (SPLINT, TRACTION)

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 lower-limb orthosis ankle/foot component, mechanical-resistance 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.

Request quotes for Lower-limb orthosis ankle/foot component, mechanical-resistance

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying lower-limb orthosis ankle/foot component, mechanic for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →