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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, nerve, transcutaneous, over-the-counter
510(k) Number K220152
Device Name TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
Hong Qiangxing (Shen Zhen) Electronics Limited
4F, Jingcheng Building, Xicheng Industrial Zone Xixiang Road
Baoan District
Shenzhen,  CN 518126
Applicant Contact Xu jianhua
Shanghai CV Technology Co., Ltd.
Room 903, No. 19 Dongbao Road, Songjiang Area,
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number882.5890
Classification Product Code
Subsequent Product Code
Date Received01/19/2022
Decision Date 04/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No