A foot-worn device designed to space the toes of the foot to relieve pain, pressure/friction between toes, and/or to facilitate realignment of the toes to a natural position. It is made of soft materials (e.g., silicone, polymer gel) and may be available in a
| Company | Devices | Share |
|---|---|---|
| Silipos Holding Llc | 24 | 39% |
| Vive Health Llc | 19 | 31% |
| Prim S.A. | 6 | 10% |
| Darco International, Inc. | 5 | 8% |
| Bird & Cronin, Llc | 4 | 6% |
| Meijer, Inc. | 1 | 2% |
| Darco (Europe) Gmbh | 1 | 2% |
| Wal-Mart Stores, Inc. | 1 | 2% |
| D-M-S Holdings, Inc. | 1 | 2% |
Company = labeler of record on GUDID. 9 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 | 43 |
| OHI | Orthosis, Foot Drop | 11 |
| KYS | Insoles, Medical | 8 |
| NOC | Splint, extremity, non-inflatable, external, non-sterile | 6 |
| KNP | Orthosis, Corrective Shoe | 1 |
Use these as the dimensions to specify in a tender line.
62 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Toe separator", from 9 companies. The largest labeler is Silipos Holding Llc with 39% of records.
FMP (Protector, Skin Pressure), OHI (Orthosis, Foot Drop), KYS (Insoles, Medical), NOC (Splint, extremity, non-inflatable, external, non-sterile)
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.