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FDA 510(k)

Pressure Therapy System

K-Number: K161907 · 2017-02-23

Decision Date2017-02-23
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Pressure Therapy System is a medical device manufactured by Xiamen Senyang Co., Ltd.. It received FDA 510(k) clearance on 2017-02-23 under approval number K161907. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pressure Therapy System?

Pressure Therapy System is a medical device that received FDA 510(k) clearance on 2017-02-23. It is manufactured by Xiamen Senyang Co., Ltd.. The 510(k) number is K161907.

When was Pressure Therapy System approved by the FDA?

Pressure Therapy System received FDA 510(k) clearance on 2017-02-23, under approval number K161907.

What company makes Pressure Therapy System?

Pressure Therapy System is manufactured by Xiamen Senyang Co., Ltd..

What is the FDA product code for Pressure Therapy System?

The FDA product code for Pressure Therapy System is IRP.

Related Clinical Trials

Related PubMed Literature

Other Devices by Xiamen Senyang Co., Ltd.

Related Devices (Code: IRP)

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.