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FDA 510(k)

Air Pressure Therapy System

K-Number: K201935 · 2021-06-22

ApplicantXiamen Weiyou Intelligent Technology Co., Ltd.
Decision Date2021-06-22
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Air Pressure Therapy System is a medical device manufactured by Xiamen Weiyou Intelligent Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-06-22 under approval number K201935. 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 Air Pressure Therapy System?

Air Pressure Therapy System is a medical device that received FDA 510(k) clearance on 2021-06-22. It is manufactured by Xiamen Weiyou Intelligent Technology Co., Ltd.. The 510(k) number is K201935.

When was Air Pressure Therapy System approved by the FDA?

Air Pressure Therapy System received FDA 510(k) clearance on 2021-06-22, under approval number K201935.

What company makes Air Pressure Therapy System?

Air Pressure Therapy System is manufactured by Xiamen Weiyou Intelligent Technology Co., Ltd..

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

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

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT07235592 PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group RECRUITING

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 Weiyou Intelligent Technology Co., Ltd.

K210967Air Pressure Therapy System: VU-IPC06 K243320Air Pressure Therapy System (VU-IPC04B) K233238Air Pressure Therapy System (Model:VU-IPC4M) K243791Air Pressure Therapy System K253064Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X)

Related Devices (Code: IRP)

K160608NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP K171685Med4 EliteCool Systems, Inc. (Dba Game Ready) K161907Pressure Therapy SystemXiamen Senyang Co., Ltd. K163280RP Lite 760RMego Afek AC , Ltd. K160178Lympha-Flow(LF1200)Daesung Maref Co., Ltd. K183169Pulse 2.0, Pulse Pro 2.0NormaTec Industries, LP

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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