Data / Medical devices / Orthosis, Foot Drop

Orthosis, Foot Drop (OHI): 68 FDA-registered makers in 16 countries

68 establishments in 16 countries are registered with the FDA to make Orthosis, Foot Drop (product code OHI, Class 1, 21 CFR 890.3475). 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 February 4, 2008, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

OHI

Device class

1

Regulation

890.3475

Medical specialty

Physical Medicine

Makers by country

Makers of Orthosis, Foot Drop

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 February 4, 2008. 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.