A prefabricated (non-customized) footwear designed as a shoe intended to support, align, prevent, and compensate for or correct deformities of the feet to help improve function and/or for post-operative therapy. This is a reusable device.
| Company | Devices | Share |
|---|---|---|
| Darco International, Inc. | 221 | 53% |
| Darco (Europe) Gmbh | 84 | 20% |
| Position Health, Llc | 47 | 11% |
| Vive Health Llc | 35 | 8% |
| Tianjin Tairuibosi Medical Appliance Co.,Ltd. | 12 | 3% |
| Asp Global, Llc | 7 | 2% |
| Cadense, Inc. | 5 | 1% |
| Deroyal Industries, Inc. | 5 | 1% |
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 |
|---|---|---|
| KNP | ORTHOSIS, CORRECTIVE SHOE | 289 |
| KNP | Orthosis, Corrective Shoe | 139 |
| IPG | Shoe, Cast | 24 |
| NOC | Splint, extremity, non-inflatable, external, non-sterile | 3 |
Use these as the dimensions to specify in a tender line.
416 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthotic shoe, non-customized", from 8 companies. The largest labeler is Darco International, Inc. with 53% of records.
KNP (ORTHOSIS, CORRECTIVE SHOE), KNP (Orthosis, Corrective Shoe), IPG (Shoe, Cast), 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.