Data / Medical devices / Insoles, Medical / United States
FDA-registered makers of Insoles, Medical in the United States: 29 establishments
29 establishments in the United States are registered with the FDA to make Insoles, Medical (product code KYS). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Insoles, Medical
- Product code
- KYS
- Country
- United States
Makers of Insoles, Medical in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Alimed, LLC | Dedham, MA, United States | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amfit, LLC. | Vancouver, WA, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Barbaras Development, Inc. | Thousand Oaks, CA, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Breg, Inc. | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CPO Labs, LLC | Peoria, IL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Feet First Orthotic Lab | Prospect, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Footscientific, Inc. | Draper, UT, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hapad, Inc | Bethel Park, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hike Medical Co. | Peoria, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ideavillage Products Corp. | Wayne, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Implus Footcare LLC | Durham, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industech International Inc. | Verona, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLM Laboratories, Inc. | Valencia, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medi-Dyne Healthcare Products, Inc. | Colleyville, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MatPLUS, LTD | Painesville, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| New Step Orthotic Lab Inc | Maryville, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| North Coast Medical, Inc. | Morgan Hill, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Northwest Podiatric Laboratory Inc | Blaine, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optec Usa, Inc. | Lawrenceville, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthofeet, Inc. | Norwood, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pittsburgh Plastics MFG., Inc. | Butler, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polygel LLC. | Palmer TWP, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Preferred Industries, Inc. | Fort Lauderdale, FL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RX Orthotic Inc | Arcadia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SILIPOS Holding LLC | Niagara Falls, NY, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solo Laboratories | Kutztown, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Span Link International LLC | Deer Park, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shock Doctor, Inc. | Costa Mesa, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.