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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 K251187
Device Name 3 in 1 TENS UNIT (TC1241, TC2241, TS1241)
Applicant
Changsha Anxiang Medical Technology Co., Ltd.
9th Floor, R&D Center And Supporting Projects 101
# 18 Shaoshan Middle Rd., Dongtang St., Yuhua District
Changsha,  CN 410007
Applicant Contact William Fu
Correspondent
Manton Business and Technology Services
37 Winding Ridge
Oakland,  NJ  07436
Correspondent Contact Melody Huang
Regulation Number882.5890
Classification Product Code
NUH  
Date Received04/17/2025
Decision Date 07/28/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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