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FDA 510(k)

Dual output digital therapy massager

K-Number: K172834 · 2018-09-06

ApplicantShenzhen Osto Technology Co., Ltd.
Decision Date2018-09-06
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Dual output digital therapy massager is a medical device manufactured by Shenzhen Osto Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-09-06 under approval number K172834. 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 Dual output digital therapy massager?

Dual output digital therapy massager is a medical device that received FDA 510(k) clearance on 2018-09-06. It is manufactured by Shenzhen Osto Technology Co., Ltd.. The 510(k) number is K172834.

When was Dual output digital therapy massager approved by the FDA?

Dual output digital therapy massager received FDA 510(k) clearance on 2018-09-06, under approval number K172834.

What company makes Dual output digital therapy massager?

Dual output digital therapy massager is manufactured by Shenzhen Osto Technology Co., Ltd..

What is the FDA product code for Dual output digital therapy massager?

The FDA product code for Dual output digital therapy massager is NUH.

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Other Devices by Shenzhen Osto Technology Co., Ltd.

K172897Neck Care Therapy, Model: SYK 509B K172837Low-frequency Multi-function physiotherapy instrument K182136Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) K212989Low-frequency Stimulator (Model: AST-645, AST-646)

Related Devices (Code: NUH)

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Official Source

View on FDA Database →

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

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