FDA 510(k) Application Details - K171978

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K171978
Device Name Stimulator, Muscle, Powered
Applicant Shenzhen Dongdixin Technology Co., Ltd.
No. 3 Building Xilibaimang Xusheng Industrial Estate
Nanshan
Shenzhen 518108 CN
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Contact Siping Yuan
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 06/30/2017
Decision Date 10/02/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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