A prefabricated orthopaedic shoe insert typically available for use by a layperson intended to provide supplemental support for the arch and/or heel of the foot, whilst inhibiting microbes such as viruses, bacteria and fungi. It is typically made of fabric and
| Company | Devices | Share |
|---|---|---|
| Foot Science International Limited | 209 | 61% |
| Silipos Holding Llc | 49 | 14% |
| Vive Health Llc | 40 | 12% |
| Alimed, Inc. | 29 | 9% |
| Ideavillage Products Corp | 13 | 4% |
Company = labeler of record on GUDID. 5 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 | 212 |
| KYS | Insoles, Medical | 46 |
| KNP | Orthosis, Corrective Shoe | 34 |
| KYS | INSOLES, MEDICAL | 29 |
| FMP | Protector, Skin Pressure | 13 |
| ITW | Joint, Ankle, External Brace | 6 |
Use these as the dimensions to specify in a tender line.
340 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthotic insole, prefabricated, antimicrobial", from 5 companies. The largest labeler is Foot Science International Limited with 61% of records.
IQI (Orthosis, Limb Brace), KYS (Insoles, Medical), KNP (Orthosis, Corrective Shoe), KYS (INSOLES, MEDICAL)
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.
Add orthotic insole, prefabricated, antimicrobial to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.
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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.