TENS And Muscle Stimulator

Stimulator, Nerve, Transcutaneous, Over-the-counter

Shenzhen As Tec Technology Co., Ltd

The following data is part of a premarket notification filed by Shenzhen As Tec Technology Co., Ltd with the FDA for Tens And Muscle Stimulator.

Pre-market Notification Details

Device IDK200727
510k NumberK200727
Device Name:TENS And Muscle Stimulator
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Shenzhen As Tec Technology Co., Ltd 8E XinBaoYi Industrial Bld, Houting Village, Beiting Road, Shajing Shenzhen,  CN 518012
ContactConnie Li
CorrespondentDoris Dong
Shanghai CV Technology Co., Ltd Room 903, No. 19 Dongbao Road, Songjiang Area Shanghai,  CN 201613
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-20
Decision Date2020-06-18

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