FDA 510(k) Application Details - K131291

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

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510(K) Number K131291
Device Name Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant JOHARI DIGITAL HEALTHCARE, LTD.
5703 OBERLIN DR.
SUITE 306
SAN DIEGO, CA 92121 US
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Contact POOJA JOHARI
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Regulation Number 890.5850

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Classification Product Code NGX
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Date Received 05/06/2013
Decision Date 06/14/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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