Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)

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 Electronic Muscle Stimulator (model: Ast-300a, Ast-300n, Ast-300s, Ast-300t, Ast-300v, Ast-300w).

Pre-market Notification Details

Device IDK211736
510k NumberK211736
Device Name:Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Shenzhen OSTO Technology Company Limited No.43 Longfeng Road, Xinsheng Community, Longgang Street Longgang District Shenzhen,  CN 518116
ContactLi Yang
CorrespondentCassis Lee
Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou,  CN 510700
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-07
Decision Date2021-09-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06950940801769 K211736 000
06950940801981 K211736 000
06950940802001 K211736 000
06950940802186 K211736 000
06950940802094 K211736 000
06950940802070 K211736 000
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