Consulting Wallah › Device Explorer › Orthopaedic implants › External lower-limb prosthesis suspensory componen
Device Explorer · FDA GUDID · GMDN 64716

External lower-limb prosthesis suspensory component, powered

A powered device intended to be integrated in the socket of an external lower limb prosthesis to provide prosthesis suspension by reducing the axial movement between the residual limb and the prosthesis, when the prosthesis is unloaded. It is designed as a vac

US‑registered devices115in commercial distribution
Companies1labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Willowwood Global Llc115100%

Top labelers

CompanyDevicesShare
Willowwood Global Llc115100%

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

Brand names on the register (sample)

OneLimbLogic

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

FDA product codes

CodeNameDevices
ISPValve, Prosthesis115
IPMCover, Limb44
ISSProsthesis, Thigh Socket, External Component44

GMDN & GCC registration

  • GMDN code 64716 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 100% · 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.

How many external lower-limb prosthesis suspensory component, powered products are registered in the US?

115 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "External lower-limb prosthesis suspensory component, powered", from 1 companies. The largest labeler is Willowwood Global Llc with 100% of records.

Which FDA product codes apply?

ISP (Valve, Prosthesis), IPM (Cover, Limb), ISS (Prosthesis, Thigh Socket, External Component)

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.

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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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