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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 K222875
Device Name Powered Muscle Stimulator (Model name:MagGraver F200)
Applicant
Nanjing Vishee Medical Technology Co., Ltd.
Building 9, No. 19, Ningshuang Road
Yuhuatai District
Nanjing,  CN 210012
Applicant Contact Kai QIU
Correspondent
Nanjing Vishee Medical Technology Co., Ltd.
Building 9, No. 19, Ningshuang Road
Yuhuatai District
Nanjing,  CN 210012
Correspondent Contact Lisa TAN
Regulation Number890.5850
Classification Product Code
NGX  
Date Received09/22/2022
Decision Date 03/09/2023
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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