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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Radio Frequency Induced Heat
510(k) Number K240991
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
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
Suwon,  KR 16648
Correspondent Contact Moon young Han
Regulation Number878.4400
Classification Product Code
PBX  
Subsequent Product Code
IPF  
Date Received04/11/2024
Decision Date 10/09/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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