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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 K250053
Device Name TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)
Applicant
Shenzhen Jiantuo Electronics Co., Ltd.
608, Block A, Zhuoyue Yulong Haoxuan, Xinyang Community
Shajing St., Bao'An District
Shenzhen,  CN 518104
Applicant Contact Jinliang Zou
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 805, # 19 Dongbao Rd., Songjiang Area, Shanghai
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received01/10/2025
Decision Date 05/09/2025
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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