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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 K190783
Device Name Health Expert Electronic Stimulator (model: AST-3000L)
Applicant
Shenzhen OSTO Technology Company Limited
No.43 Longfeng Road, Xinsheng Community, Longgang Street
Longgang District,Shenzhen City,  CN 518116
Applicant Contact Li Yang
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
Room 2231, Building 1, Ruifeng center, Kaichuang road
Huangpu district
Guangzhou,  CN 51006
Correspondent Contact Cassie Lee
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received03/27/2019
Decision Date 03/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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