Low-frequency Multi-function Physiotherapy Instrument

Stimulator, Nerve, Transcutaneous, Over-the-counter

Shenzhen OSTO Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Osto Technology Co., Ltd. with the FDA for Low-frequency Multi-function Physiotherapy Instrument.

Pre-market Notification Details

Device IDK172837
510k NumberK172837
Device Name:Low-frequency Multi-function Physiotherapy Instrument
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Shenzhen OSTO Technology Co., Ltd. No.43 Longfeng Road, Xinsheng Community Longgang Street Longgang District Shenzhen,  CN
ContactLi Yang
CorrespondentCecilia Ceng
Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou,  CN 510006
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-19
Decision Date2018-11-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06950940801486 K172837 000
06950940801530 K172837 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.