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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 K182136
Device Name Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
Applicant
Shenzhen OSTO Technology Co., Ltd.
No.43 Longfeng Road, Xinsheng Community
shenzhen,  CN
Applicant Contact li yang
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
Suite 306, Kecheng Mansion, No.121 Science Road
Guangzhou Science Park
guangzhou,  CN 510663
Correspondent Contact cassie lee
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received08/06/2018
Decision Date 10/10/2019
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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