EV-804 OTC Pain Relief TENS

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 Ev-804 Otc Pain Relief Tens.

Pre-market Notification Details

Device IDK172919
510k NumberK172919
Device Name:EV-804 OTC Pain Relief TENS
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Everyway Medical Instruments Co., Ltd. 3Fl., No. 5, Lane 155, Sec. 3, Peishen Rd. Shenkeng Dist New Taipei City,  TW 22203
ContactPaul Hung
CorrespondentPaul Hung
Everyway Medical Instruments Co., Ltd. 3Fl., No. 5, Lane 155, Sec. 3, Peishen Rd. Shenkeng Dist New Taipei City,  TW 22203
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-25
Decision Date2018-04-19

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