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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
510(k) Number K240992
Device Name eMVFit (MVF-10M)
Applicant
Weero Co., Ltd.
A-605, Venture Valley Ii, 142-10, Saneop-Ro 156 Beon-Gil,
Gwonseon-Gu Suwon-Si,Gyeonggi-Do
Suwon,  KR 16648
Applicant Contact Moon young Han
Correspondent
Weero Co., Ltd.
A-605, Venture Valley Ii, 142-10, Saneop-Ro 156 Beon-Gil,
Gwonseon-Gu Suwon-Si,Gyeonggi-Do
Suwon,  KR 16648
Correspondent Contact Moon young Han
Regulation Number890.5850
Classification Product Code
IPF  
Date Received04/11/2024
Decision Date 10/10/2024
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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