A non-powered device intended to be integrated in the socket shell of an external lower limb prosthesis to reduce the axial movement between the residual limb and the prosthesis, when the prosthesis is unloaded. It may be designed in various forms (e.g., strap
| Company | Devices | Share |
|---|---|---|
| Alps South, Llc | 210 | 70% |
| Cypress Adaptive, Llc | 80 | 27% |
| Trulife Limited | 7 | 2% |
| Streifeneder Ortho.Production Gmbh | 3 | 1% |
Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| ISS | Prosthesis, Thigh Socket, External Component | 235 |
| ISP | Valve, Prosthesis | 49 |
| IRA | Hand, External Limb Component, Mechanical | 39 |
| ISH | COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT | 7 |
| IPM | Cover, Limb | 5 |
| ISY | Joint, Knee, External Limb Component | 2 |
Use these as the dimensions to specify in a tender line.
300 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, non-powered", from 4 companies. The largest labeler is Alps South, Llc with 70% of records.
ISS (Prosthesis, Thigh Socket, External Component), ISP (Valve, Prosthesis), IRA (Hand, External Limb Component, Mechanical), ISH (COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT)
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.