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FDA 510(k)

Pressure Therapy System PT1003

K-Number: K181409 · 2019-02-19

ApplicantXiamen Senyang Co., Ltd.
Decision Date2019-02-19
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Pressure Therapy System PT1003 is a medical device manufactured by Xiamen Senyang Co., Ltd.. It received FDA 510(k) clearance on 2019-02-19 under approval number K181409. 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 PT1003?

Pressure Therapy System PT1003 is a medical device that received FDA 510(k) clearance on 2019-02-19. It is manufactured by Xiamen Senyang Co., Ltd.. The 510(k) number is K181409.

When was Pressure Therapy System PT1003 approved by the FDA?

Pressure Therapy System PT1003 received FDA 510(k) clearance on 2019-02-19, under approval number K181409.

What company makes Pressure Therapy System PT1003?

Pressure Therapy System PT1003 is manufactured by Xiamen Senyang Co., Ltd..

What is the FDA product code for Pressure Therapy System PT1003?

The FDA product code for Pressure Therapy System PT1003 is IRP.

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Related PubMed Literature

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Other Devices by Xiamen Senyang Co., Ltd.

K161907Pressure Therapy System K192358Pressure Therapy System PT1003

Related Devices (Code: IRP)

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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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