A battery-powered electromechanical 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 motion con
| Company | Devices | Share |
|---|---|---|
| Otto Bock Healthcare | 378 | 51% |
| College Park Industries, Inc. | 360 | 49% |
Company = labeler of record on GUDID. 2 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 |
|---|---|---|
| ISW | Assembly, Knee/Shank/Ankle/Foot, External | 378 |
| ISH | Component, External, Limb, Ankle/Foot | 360 |
Use these as the dimensions to specify in a tender line.
738 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Mechatronic external ankle-foot prosthesis", from 2 companies. The largest labeler is Otto Bock Healthcare with 51% of records.
ISW (Assembly, Knee/Shank/Ankle/Foot, External), 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.