Data / Medical devices / Orthosis, Limb Brace

Orthosis, Limb Brace (IQI): 441 FDA-registered makers in 41 countries

441 establishments in 41 countries are registered with the FDA to make Orthosis, Limb Brace (product code IQI, Class 1, 21 CFR 890.3475). 1 of them has a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 52 510(k) clearances under this code, the latest on August 13, 2015, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

IQI

Device class

1

Regulation

890.3475

Medical specialty

Physical Medicine

Makers by country

Makers of Orthosis, Limb Brace

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 August 13, 2015. 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.