FDA 510(k) Application Details - K133965

Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning

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510(K) Number K133965
Device Name Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
No. 3 Building XiliBaimang Xusheng Industrial Estate
Nanshan
SHENZHEN 518108 CN
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Contact QILIAN LIU
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Regulation Number 890.5850

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Classification Product Code NGX
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Date Received 12/24/2013
Decision Date 06/16/2014
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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