Data / Medical devices / Insoles, Medical

Insoles, Medical (KYS): 105 FDA-registered makers in 19 countries

105 establishments in 19 countries are registered with the FDA to make Insoles, Medical (product code KYS, Class 1, 21 CFR 880.6280). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on October 10, 1978, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

KYS

Device class

1

Regulation

880.6280

Medical specialty

General Hospital

Makers by country

Makers of Insoles, Medical

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated October 10, 1978. 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.