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FDA 510(k)

Pressure Therapy System PT1003

K-Number: K192358 · 2020-04-23

ApplicantXiamen Senyang Co., Ltd.
Decision Date2020-04-23
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 2020-04-23 under approval number K192358. 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 2020-04-23. It is manufactured by Xiamen Senyang Co., Ltd.. The 510(k) number is K192358.

When was Pressure Therapy System PT1003 approved by the FDA?

Pressure Therapy System PT1003 received FDA 510(k) clearance on 2020-04-23, under approval number K192358.

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

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025) PMID: 40610624 Impact of a novel smartphone application for remote monitoring of gestational diabetes on glycaemic control and birth outcomes: a pilot observational study. Scientific reports (2025)

Other Devices by Xiamen Senyang Co., Ltd.

K161907Pressure Therapy System K181409Pressure 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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