A prefabricated (non-customized) device intended to be worn against the feet to reduce peak foot pressures and improve pedal circulation in a patient who has, or who is at risk of developing, peripheral vascular disease (PVD) or diabetic foot disease. It typic
| Company | Devices | Share |
|---|---|---|
| Darco International, Inc. | 57 | 98% |
| Darco (Europe) Gmbh | 1 | 2% |
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 |
|---|---|---|
| FMP | Protector, skin pressure | 34 |
| FMP | Protector, Skin Pressure | 23 |
| KNP | ORTHOSIS, CORRECTIVE SHOE | 8 |
Use these as the dimensions to specify in a tender line.
58 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pressure-management insole, prefabricated", from 2 companies. The largest labeler is Darco International, Inc. with 98% of records.
FMP (Protector, skin pressure), FMP (Protector, Skin Pressure), KNP (ORTHOSIS, CORRECTIVE SHOE)
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.