FDA 510(k)

Neck Care Therapy, Model: SYK 509B

K-Number: K172897 · 2018-12-07

ApplicantShenzhen Osto Technology Co., Ltd.

Decision Date2018-12-07

Product CodeNUH

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Neck Care Therapy, Model: SYK 509B is a medical device manufactured by Shenzhen Osto Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-12-07 under approval number K172897. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neck Care Therapy, Model: SYK 509B?

Neck Care Therapy, Model: SYK 509B is a medical device that received FDA 510(k) clearance on 2018-12-07. It is manufactured by Shenzhen Osto Technology Co., Ltd.. The 510(k) number is K172897.

When was Neck Care Therapy, Model: SYK 509B approved by the FDA?

Neck Care Therapy, Model: SYK 509B received FDA 510(k) clearance on 2018-12-07, under approval number K172897.

What company makes Neck Care Therapy, Model: SYK 509B?

Neck Care Therapy, Model: SYK 509B is manufactured by Shenzhen Osto Technology Co., Ltd..

What is the FDA product code for Neck Care Therapy, Model: SYK 509B?

The FDA product code for Neck Care Therapy, Model: SYK 509B is NUH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.