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Data / Medical devices / External Mechanical Stimulator For The Relief Of Congestion

External Mechanical Stimulator For The Relief Of Congestion (QZC): 3 FDA-registered makers in 3 countries

3 establishments in 3 countries are registered with the FDA to make External Mechanical Stimulator For The Relief Of Congestion (product code QZC, Class 2, 21 CFR 874.6010). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on April 24, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
QZC
Device class
2
Regulation
874.6010
Medical specialty
Ear, Nose, Throat

Makers by country

CountryMakers
United States1
China1
Taiwan1

Makers of External Mechanical Stimulator For The Relief Of Congestion

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
Sound Health Systems, Inc.San Jose, CA, United StatesComplaint file establishment, Specification developer1April 24, 2025000api.fda.gov
Yahorng Dongguan Electronic Co LtdGuangdong, ChinaContract manufacturer0000api.fda.gov
Ya Horng Electronic Co., Ltd.Tainan, TaiwanContract manufacturer0000api.fda.gov

Updated April 24, 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.