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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 K200727
Device Name TENS and Muscle Stimulator
Shenzhen As Tec Technology Co., Ltd
8E XinBaoYi Industrial Bld, Houting Village, Beiting Road,
Shenzhen,  CN 518012
Applicant Contact Connie Li
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 Received03/20/2020
Decision Date 06/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No