A prefabricated shoe insert typically available for use by a layperson intended to provide supplemental support for the arch and/or heel of the foot; it does not include an antimicrobial agent(s). This is a reusable device.
| Company | Devices | Share |
|---|---|---|
| Medi Manufacturing, Inc. | 521 | 47% |
| Hapad Inc | 147 | 13% |
| Erismet Ou | 103 | 9% |
| Darco (Europe) Gmbh | 79 | 7% |
| Alimed, Inc. | 63 | 6% |
| Foot Science International Limited | 45 | 4% |
| Brownmed, Inc. | 44 | 4% |
| Vive Health Llc | 39 | 4% |
| Tetra Medical Supply Corp. | 28 | 3% |
| Bailey Instruments Ltd | 7 | 1% |
| Shock Doctor, Inc. | 7 | 1% |
| Djo, Llc | 6 | 1% |
Company = labeler of record on GUDID. 16 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 |
|---|---|---|
| IQI | ORTHOSIS, LIMB BRACE | 649 |
| KYS | Insoles, Medical | 359 |
| IQI | Orthosis, Limb Brace | 89 |
| FMP | Protector, skin pressure | 70 |
| KYS | INSOLES, MEDICAL | 70 |
| KNP | Orthosis, Corrective Shoe | 37 |
Use these as the dimensions to specify in a tender line.
1,109 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthotic insole, prefabricated, non-antimicrobial", from 16 companies. The largest labeler is Medi Manufacturing, Inc. with 47% of records.
IQI (ORTHOSIS, LIMB BRACE), KYS (Insoles, Medical), IQI (Orthosis, Limb Brace), FMP (Protector, skin pressure)
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.