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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 K243856
Device Name TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)
Applicant
Shenzhen Astec Technology Co., Ltd.
808 Xinbaoyi Industrial Bld, Houting Village Beiting Rd.
Shenzhen,  CN 518104
Applicant Contact Connie Li
Correspondent
Shenzhen Astec Technology Co., Ltd.
808 Xinbaoyi Industrial Bld, Houting Village Beiting Rd.
Shenzhen,  CN 518104
Correspondent Contact Connie Li
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received12/16/2024
Decision Date 05/29/2025
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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