Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10

Stimulator, Muscle, Powered

Shenzhen Dongdixin Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co., Ltd. with the FDA for Combo Stimulator Mt9000, Combo Stimulator Lt7102, Tens Stimulator Intensity 10.

Pre-market Notification Details

Device IDK171978
510k NumberK171978
Device Name:Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
ClassificationStimulator, Muscle, Powered
Applicant Shenzhen Dongdixin Technology Co., Ltd. No. 3 Building Xilibaimang Xusheng Industrial Estate Nanshan Shenzhen,  CN 518108
ContactSiping Yuan
CorrespondentSiping Yuan
Shenzhen Dongdixin Technology Co., Ltd. No. 3 Building Xilibaimang Xusheng Industrial Estate Nanshan Shenzhen,  CN 518108
Product CodeIPF  
Subsequent Product CodeGZJ
Subsequent Product CodeLIH
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-30
Decision Date2017-10-02
Summary:summary

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