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Data / Medical devices / Stimulator, Nerve, For Restless Legs Syndrome

Stimulator, Nerve, For Restless Legs Syndrome (QWD): 3 FDA-registered makers in 3 countries

3 establishments in 3 countries are registered with the FDA to make Stimulator, Nerve, For Restless Legs Syndrome (product code QWD, Class 2, 21 CFR 882.5887). 1 of them has 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 April 17, 2023, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.

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Product code
QWD
Device class
2
Regulation
882.5887
Medical specialty
Neurology

Makers by country

CountryMakers
United States1
Singapore1
China1

Makers of Stimulator, Nerve, For Restless Legs Syndrome

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Noctrix Health, Inc.Pleasanton, CA, United StatesComplaint file establishment, Specification developer1April 17, 2023000api.fda.gov
Racer Technology Pte LtdSINGAPORE South East, SingaporeContract manufacturer0000api.fda.gov
Teleray Smart Technologies (dongguan) Co.,ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov

Updated April 17, 2023. 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.