Everyway Wireless TENS & EMS Unit

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 Everyway Wireless Tens & Ems Unit.

Pre-market Notification Details

Device IDK181707
510k NumberK181707
Device Name:Everyway Wireless TENS & EMS Unit
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 Received2018-06-28
Decision Date2018-09-26

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