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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 K213748
Device Name CoreLevee
Applicant
Lutronic Corporation
Lutronic Center, 219, Sowon-Ro
Deogyang-Gu, Goyang-si,  KR 410220
Applicant Contact Haewon Park
Correspondent
Lutronic Corporation
Lutronic Center, 219, Sowon-Ro
Deogyang-Gu, Goyang-si,  KR 410220
Correspondent Contact Haewon Park
Regulation Number890.5850
Classification Product Code
NGX  
Date Received11/30/2021
Decision Date 10/14/2022
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
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