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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 K212866
Device Name truSculpt flex
Applicant
Johari Digital Healthcare Limited
G-582, 584 Epip, Boranda
Jodhpur,  IN 342012
Applicant Contact Pooja Johari
Correspondent
Johari Digital Healthcare Limited
G-582, 584 Epip, Boranda
Jodhpur,  IN 342012
Correspondent Contact Pooja Johari
Regulation Number890.5850
Classification Product Code
NGX  
Date Received09/08/2021
Decision Date 12/03/2022
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
Predetermined Change
Control Plan Authorized		 No
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