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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning
510(k) Number K262470
Device Name Dual-Channel TENS & EMS Muscle Stimulator (Models TS1111, TS4111)
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 410000
Applicant Contact Yoyo Yang
Correspondent
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 410000
Correspondent Contact Yoyo Yang
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Codes
NUH   NYN  
Date Received07/17/2026
Decision Date 10/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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