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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 K192039
Device Name Torc Body
Applicant
Johari Digital Healthcare Limited
G-582, 584 EPIP, Boranada
Jodhpur,  IN 342008
Applicant Contact Pooja Johari
Correspondent
Johari Digital Healthcare Limited
G-582, 584 EPIP, Boranada
Jodhpur,  IN 342008
Correspondent Contact Pooja Johari
Regulation Number890.5850
Classification Product Code
NGX  
Date Received07/30/2019
Decision Date 03/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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