Data / Medical devices / Amplifier, Physiological Signal

Amplifier, Physiological Signal (GWL): 23 FDA-registered makers in 10 countries

23 establishments in 10 countries are registered with the FDA to make Amplifier, Physiological Signal (product code GWL, Class 2, 21 CFR 882.1835). 16 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 53 510(k) clearances under this code, the latest on March 12, 2025, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

GWL

Device class

2

Regulation

882.1835

Medical specialty

Neurology

Makers by country

Makers of Amplifier, Physiological Signal

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 March 12, 2025. 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.