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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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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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