FDA 510(k) Application Details - K162987

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K162987
Device Name Stimulator, Muscle, Powered
Applicant FlowAid Medical Technologies, Corp
44 Wall Street
New York, NY 10005 US
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Contact Jacob Brezel
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 10/27/2016
Decision Date 02/14/2017
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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