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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 K253305
Device Name TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
Applicant
Shenzhen Jiantuo Electronics Co., Ltd.
608, Block A, Zhuoyue Yulong Haoxuan, Xinyang Community
Shajing St., Bao'An District, Shenzhen City
Shenzhen,  CN 518104
Applicant Contact Jin Liang Zou
Correspondent
Shenzhen Jiantuo Electronics Co., Ltd.
608, Block A, Zhuoyue Yulong Haoxuan, Xinyang Community
Shajing St., Bao'An District, Shenzhen City
Shenzhen,  CN 518104
Correspondent Contact Jin Liang Zou
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received09/29/2025
Decision Date 12/31/2025
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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