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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered, for muscle conditioning
510(k) Number K131291
Device Name TORC BODY
Applicant
JOHARI DIGITAL HEALTHCARE, LTD.
5703 OBERLIN DR.
SUITE 306
SAN DIEGO,  CA  92121
Applicant Contact POOJA JOHARI
Correspondent
JOHARI DIGITAL HEALTHCARE, LTD.
5703 OBERLIN DR.
SUITE 306
SAN DIEGO,  CA  92121
Correspondent Contact POOJA JOHARI
Regulation Number890.5850
Classification Product Code
NGX  
Date Received05/06/2013
Decision Date 06/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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