TENS AND POWERED 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 Powered Muscle Stimulator.

Pre-market Notification Details

Device IDK143268
510k NumberK143268
Device Name:TENS AND POWERED MUSCLE STIMULATOR
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant SHENZHEN AS-TEC TECHNOLOGY CO., LTD 2C XINGBAOYI INDUSTRIAL BLD., HOUTING VILLAGE, BEITING RD., SHAJING Shenzhen,  CN 518104
ContactConnie Li
CorrespondentDoris Dong
SHANGHAI CV TECHNOLOGY CO., LTD ROOM 1706 YUESHA BUILDING, NO.128 SONGLE RD., SONGJIANG AREA Shanghai,  CN 201600
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-13
Decision Date2015-07-21

NIH GUDID Devices

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