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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Alimed, LLCDedham, MA, United StatesContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Amfit, LLC.Vancouver, WA, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Barbaras Development, Inc.Thousand Oaks, CA, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
Breg, Inc.Carlsbad, CA, United StatesSpecification developer0000api.fda.gov
CPO Labs, LLCPeoria, IL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Feet First Orthotic LabProspect, OH, United StatesManufacturer0000api.fda.gov
Footscientific, Inc.Draper, UT, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Hapad, IncBethel Park, PA, United StatesManufacturer0000api.fda.gov
Hike Medical Co.Peoria, IL, United StatesManufacturer0000api.fda.gov
Ideavillage Products Corp.Wayne, NJ, United StatesSpecification developer0000api.fda.gov
Implus Footcare LLCDurham, NC, United StatesSpecification developer0000api.fda.gov
Industech International Inc.Verona, NJ, United StatesManufacturer0000api.fda.gov
KLM Laboratories, Inc.Valencia, CA, United StatesManufacturer0000api.fda.gov
Medi-Dyne Healthcare Products, Inc.Colleyville, TX, United StatesSpecification developer0000api.fda.gov
MatPLUS, LTDPainesville, OH, United StatesManufacturer0000api.fda.gov
New Step Orthotic Lab IncMaryville, IL, United StatesManufacturer0000api.fda.gov
North Coast Medical, Inc.Morgan Hill, CA, United StatesManufacturer0000api.fda.gov
Northwest Podiatric Laboratory IncBlaine, WA, United StatesManufacturer0000api.fda.gov
Optec Usa, Inc.Lawrenceville, GA, United StatesManufacturer0000api.fda.gov
Orthofeet, Inc.Norwood, NJ, United StatesManufacturer0000api.fda.gov
Pittsburgh Plastics MFG., Inc.Butler, PA, United StatesContract manufacturer0000api.fda.gov
Polygel LLC.Palmer TWP, PA, United StatesSpecification developer0000api.fda.gov
Preferred Industries, Inc.Fort Lauderdale, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
RX Orthotic IncArcadia, CA, United StatesContract manufacturer0000api.fda.gov
SILIPOS Holding LLCNiagara Falls, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Solo LaboratoriesKutztown, PA, United StatesManufacturer0000api.fda.gov
Span Link International LLCDeer Park, NY, United StatesSpecification developer0000api.fda.gov
Shock Doctor, Inc.Costa Mesa, CA, United StatesSpecification developer0000api.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.