Dual Output Digital Therapy Massager

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 Dual Output Digital Therapy Massager.

Pre-market Notification Details

Device IDK172834
510k NumberK172834
Device Name:Dual Output Digital Therapy Massager
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 Date2018-09-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06950940801165 K172834 000
06950940801394 K172834 000
06950940801318 K172834 000
06950940801608 K172834 000
06950940801899 K172834 000
06950940801936 K172834 000
06950940801967 K172834 000
06950940802032 K172834 000

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