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Electrical Tongue Stimulator To Treat Motor Deficits

Regulation 882.5889

1510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in QCF

Company510(k)sRecalls
Helius Medical, Inc.20
Decided510(k)Device and applicantCode
May 13, 2026K253061Portable Neuromodulation Stimulator (PoNS)
Helius Medical, Inc.
QCF
Mar 26, 2021DEN200050Portable Neuromodulation Stimulator (PoNS)
Helius Medical, Inc.
QCF

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