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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K213078
Device Name Myolift QT
Applicant
Johari Digital Healthcare Limited
G-582, 584 Epip, Boranda
Jodhpur,  IN 342012
Applicant Contact Pooja Johari
Correspondent
7D Wellness
1345 Encinitas Blvd.,# 538
Encinitas,  CA  92024
Correspondent Contact Pooja Johari
Regulation Number882.5890
Classification Product Code
NFO  
Date Received09/23/2021
Decision Date 04/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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