Health Expert Electronic Stimulator (model: AST-3000L)

Stimulator, Nerve, Transcutaneous, Over-the-counter

Shenzhen OSTO Technology Company Limited

The following data is part of a premarket notification filed by Shenzhen Osto Technology Company Limited with the FDA for Health Expert Electronic Stimulator (model: Ast-3000l).

Pre-market Notification Details

Device IDK190783
510k NumberK190783
Device Name:Health Expert Electronic Stimulator (model: AST-3000L)
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Shenzhen OSTO Technology Company Limited No.43 Longfeng Road, Xinsheng Community, Longgang Street Longgang District,shenzhen City,  CN 518116
ContactLi Yang
CorrespondentCassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd. Room 2231, Building 1, Ruifeng Center, Kaichuang Road Huangpu District Guangzhou,  CN 51006
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
510k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-27
Decision Date2020-03-14

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