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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
7E 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
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