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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 K242567
Device Name Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
Applicant
Changsha Anxiang Medical Technology Co., Ltd.
9th Floor, R&D Center And Supporting Projects 101,
#18 Shanshan Middle Rd., Dongtang St., Yuhua District
Changsha,  CN 410000
Applicant Contact William Fu
Correspondent
Changsha Anxiang Medical Technology Co., Ltd.
9th Floor, R&D Center And Supporting Projects 101,
#18 Shanshan Middle Rd., Dongtang St., Yuhua District
Changsha,  CN 410000
Correspondent Contact William Fu
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received08/29/2024
Decision Date 11/04/2024
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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