A mechanical device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent foot and/or ankle, wherein the principle of operation for dorsiflexion/plantar flexion control is based on media-free me
| Company | Devices | Share |
|---|---|---|
| College Park Industries, Inc. | 20,332 | 88% |
| Alps South, Llc | 1,412 | 6% |
| Trulife Limited | 1,194 | 5% |
| C Lindhextend Ab | 273 | 1% |
| Streifeneder Ortho.Production Gmbh | 8 | 0% |
| Axiles Bionics | 6 | 0% |
| Teh Lin Prosthetic & Orthopaedic Inc. | 1 | 0% |
| Impulse Technology, Llc. | 1 | 0% |
Company = labeler of record on GUDID. 8 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 |
|---|---|---|
| ISH | Component, External, Limb, Ankle/Foot | 22,118 |
| ISH | COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT | 1,117 |
Use these as the dimensions to specify in a tender line.
23,227 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Mechanical-resistance external ankle-foot prosthesis", from 8 companies. The largest labeler is College Park Industries, Inc. with 88% of records.
ISH (Component, External, Limb, Ankle/Foot), 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.