Air Pressure Therapy System - Air Pressure Therapy System (VU-IPC4X)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K253064

by Xiamen Weiyou Intelligent Technology Co., Ltd

Identifiers

510(k) Number: K253064 FDA 510(k)
FDA Product Code: IRP FDA 510(k)
Models / Variants: Air Pressure Therapy System (VU-IPC8M) FDA 510(k)EUDAMED
Air Pressure Therapy System (VU-IPC6M) FDA 510(k)EUDAMED
Air Pressure Therapy System (VU-IPC4X) FDA 510(k)EUDAMED

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 890.5650 FDA 510(k)
Regulation Number: 890.5650 FDA 510(k)
Advisory Committee: Physical Medicine FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Air Pressure Therapy System (VU-IPC8M, VU-IPC6M, VU-IPC4X) is a Powered Inflatable Tube Massager, designed to deliver intermittent pneumatic compression therapy. It applies controlled air pressure to limbs or other body parts to improve circulation, reduce swelling, and promote lymphatic drainage, commonly used in physical medicine settings.

This system is supplied as a reusable medical device, intended for clinical or home use under professional supervision. It operates with varying pressure settings (as indicated by model-specific codes) and is classified as Class II under FDA regulations. The device requires proper calibration, cleaning, and storage per manufacturer instructions to ensure sterility and functionality. Authorisations include FDA 510K clearance and MDR compliance, with no specific MRI safety restrictions noted.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K253064	Class II	Active

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Manufacturer

Manufacturer: Xiamen Weiyou Intelligent Technology Co., Ltd
FDA Applicant: Xiamen Weiyou Intelligent Technology Co., Ltd.

Sources (2)

FDA 510(k) K253064 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced May 19, 2026