FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL

Stimulator, Muscle, Powered, For Muscle Conditioning

FAMIDOC TECHNOLOGY CO., LTD

The following data is part of a premarket notification filed by Famidoc Technology Co., Ltd with the FDA for Fdes106 Mini Tens&ems Device,fdes106 Multi-function Mini Tens&ems Device,fdes105 Pain Relief Plaster,fdes107 Abdominal.

Pre-market Notification Details

Device IDK130723
510k NumberK130723
Device Name:FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant FAMIDOC TECHNOLOGY CO., LTD No.212 Yilong Road, Hexi Industrial Zone, Jinxia, Changan Town Dongguan,  CN 523853
ContactReanny Wang
CorrespondentReanny Wang
FAMIDOC TECHNOLOGY CO., LTD No.212 Yilong Road, Hexi Industrial Zone, Jinxia, Changan Town Dongguan,  CN 523853
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-18
Decision Date2014-02-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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