Neck Care Therapy, Model: SYK 509B

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 Neck Care Therapy, Model: Syk 509b.

Pre-market Notification Details

Device IDK172897
510k NumberK172897
Device Name:Neck Care Therapy, Model: SYK 509B
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
CorrespondentCassie Lee
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 Received2017-09-22
Decision Date2018-12-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06950940801448 K172897 000
06950940801462 K172897 000
06950940801639 K172897 000

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