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FDA 510(k)

Air Pressure Therapy System (VU-IPC04B)

K-Number: K243320 · 2024-11-18

ApplicantXiamen Weiyou Intelligent Technology Co., Ltd.
Decision Date2024-11-18
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Air Pressure Therapy System (VU-IPC04B) is a medical device manufactured by Xiamen Weiyou Intelligent Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-18 under approval number K243320. 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 (VU-IPC04B)?

Air Pressure Therapy System (VU-IPC04B) is a medical device that received FDA 510(k) clearance on 2024-11-18. It is manufactured by Xiamen Weiyou Intelligent Technology Co., Ltd.. The 510(k) number is K243320.

When was Air Pressure Therapy System (VU-IPC04B) approved by the FDA?

Air Pressure Therapy System (VU-IPC04B) received FDA 510(k) clearance on 2024-11-18, under approval number K243320.

What company makes Air Pressure Therapy System (VU-IPC04B)?

Air Pressure Therapy System (VU-IPC04B) is manufactured by Xiamen Weiyou Intelligent Technology Co., Ltd..

What is the FDA product code for Air Pressure Therapy System (VU-IPC04B)?

The FDA product code for Air Pressure Therapy System (VU-IPC04B) 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.

K201935Air Pressure Therapy System K210967Air Pressure Therapy System: VU-IPC06 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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