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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 K250784
Device Name Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)
Applicant
Shenzhen Yicai Health Technology Co., Ltd.
11th Floor, Zhenqian Bldg., Yousong Community
Longhua St., Longhua District
Shenzhen,  CN 518110
Applicant Contact Jie Xie
Correspondent
Shenzhen Yicai Health Technology Co., Ltd.
11th Floor, Zhenqian Bldg., Yousong Community
Longhua St., Longhua District
Shenzhen,  CN 518110
Correspondent Contact Jie Xie
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received03/14/2025
Decision Date 08/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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