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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 K260412
Device Name TENS 7000 Rechargeable 4 Channel (TENS 7000H)
Applicant
Shenzhen Dongdixin Technology Co., Ltd.
Floor 1-2, #3 Bldg., Fanshen Xusheng Industrial Estate
Xilixiaobaimang, Nanshan District
Shenzhen,  CN 518108
Applicant Contact Siping Yuan
Correspondent
Shenzhen Dongdixin Technology Co., Ltd.
Floor 1-2, #3 Bldg., Fanshen Xusheng Industrial Estate
Xilixiaobaimang, Nanshan District
Shenzhen,  CN 518108
Correspondent Contact Siping Yuan
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
NGX   NYN  
Date Received02/09/2026
Decision Date 06/26/2026
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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