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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 K201354
Device Name TENS & PMS
Applicant
Hong Qiangxing (Shen Zhen) Electronics Limited
4F, Jingcheng Building, Xicheng Industrial Zone
Xixiang Road, Baoan
Shenzhen,  CN 518126
Applicant Contact Linda Liao
Correspondent
Shanghai CV Technology Co., Ltd.
Room 903, No. 19 Dongbao Road, Songjiang Area,
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
NUH  
Date Received05/21/2020
Decision Date 12/11/2020
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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