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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 K251706
Device Name TENS and EMS Unit
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 William (Qunqi) Fu
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 William (Qunqi) Fu
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
NUH  
Date Received06/03/2025
Decision Date 07/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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