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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 K212184
Device Name TENS and EMS Stimulation (OTC)
Changsha Yuwen Medical Equipment Co.,Ltd.
Room 2404, Kairui Building, No. 245 Laodong West Road,
Tianxin District, Changsha, Hunan.
Changsha,  CN 410004
Applicant Contact Dahui Chen
Microkn Business Consulting (Shanghai) Co., Ltd
Room 1215, Block A, No 3699, Gonghexin Road,
Jingan District, Shanghai, China
Shanghai,  CN 200435
Correspondent Contact Eva Li
Regulation Number882.5890
Classification Product Code
Subsequent Product Code
Date Received07/13/2021
Decision Date 04/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No