HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2

Stimulator, Nerve, Transcutaneous, Over-the-counter

Hivox Biotek Inc.

The following data is part of a premarket notification filed by Hivox Biotek Inc. with the FDA for Hivox Otc Electrical Stimulator, Em59-l, Hivox Otc Electrical Stimulator, Em59-2.

Pre-market Notification Details

Device IDK203574
510k NumberK203574
Device Name:HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Hivox Biotek Inc. SF, No. 123, Xingde Road, Sanchong District, New Taipei City,  TW 241
ContactRuby Lu
CorrespondentRuby Lu
Hivox Biotek Inc. 5F, No. 123, Xingde Road, Sanchong District, New Taipei City,  TW 241
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-07
Decision Date2021-03-10

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