Li-Battery Powered OTC TENS/EMS Combination Stimulator

Stimulator, Nerve, Transcutaneous, Over-the-counter

Everyway Medical Instruments Co., Ltd

The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd with the FDA for Li-battery Powered Otc Tens/ems Combination Stimulator.

Pre-market Notification Details

Device IDK201335
510k NumberK201335
Device Name:Li-Battery Powered OTC TENS/EMS Combination Stimulator
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Everyway Medical Instruments Co., Ltd 3FL., No.5, Lane 155, Section 3, Peishen Rd., Shenkeng District, New Taipei City,  TW 22203
ContactPaul Hung
CorrespondentPaul Hung
Everyway Medical Instruments Co., Ltd 3FL., No.5, Lane 155, Section 3, Peishen Rd., Shenkeng District, New Taipei City,  TW 22203
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-20
Decision Date2020-10-24

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