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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 K212989
Device Name Low-frequency Stimulator (Model: AST-645, AST-646)
Applicant
Shenzhen OSTO Technology Co., Ltd.
No.43 Longfeng Road, Xinsheng Community Longgang
Street Longgang District
Shenzhen,  CN 518116
Applicant Contact Li Yang
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Building 1, Rui Feng Center, Kaichuang Road,
Huangpu District
Guangzhou,  CN 510700
Correspondent Contact Cassie Lee
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
GZJ   IPF   IRT   NGX   NYN  
Date Received09/20/2021
Decision Date 11/22/2021
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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