FDA 510(k) Application Details - K151722

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

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510(K) Number K151722
Device Name Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant AIME MEDICAL INC
1258 WEST BAY DRIVE, SUITE F
LARGO, FL 33770 US
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Contact PAUL GUILBAUD
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Regulation Number 890.5850

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Classification Product Code NGX
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Date Received 06/25/2015
Decision Date 03/18/2016
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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