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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 K220198
Device Name Medi Lift PLUS
Applicant
Ya-Man, Ltd.
2-4-2 Toyo
Koto-Ku,  JP 1350016
Applicant Contact Jun Takada
Correspondent
Hogan Lovells US Lpp
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact Jonathan S. Kahan
Regulation Number882.5890
Classification Product Code
NFO  
Date Received01/24/2022
Decision Date 06/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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