Air Pressure Therapy System VU-IPC4M
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233238 FDA 510(k)
- FDA Product Code
- IRP FDA 510(k)
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-IPC4M is a powered inflatable tube massager designed for physical medicine applications. It delivers controlled air pressure to targeted muscle groups, aiding in relaxation, circulation improvement, and pain relief through rhythmic compression therapy.
This device is intended for single-use or reusable clinical settings, depending on manufacturer guidelines, and is classified as a Class II medical device under FDA regulations. It operates without MRI compatibility restrictions and is supplied as a complete system, including tubing and pressure control components. Authorisations include FDA 510(k) clearance and compliance with the Medical Device Regulation (MDR)
Frequently asked questions
What clinical applications is the Air Pressure Therapy System (Model: VU-IPC4M) primarily used for?
The Air Pressure Therapy System (VU-IPC4M) is designed for physical medicine applications, specifically to deliver controlled air pressure to targeted muscle groups. It aids in relaxation, improves circulation, and provides pain relief through rhythmic compression therapy, making it useful for muscle recovery, edema management, and post-exercise or post-injury rehabilitation.
Is the Air Pressure Therapy System (VU-IPC4M) safe to use in an MRI environment?
Yes, the VU-IPC4M is explicitly stated to have no MRI compatibility restrictions, meaning it can be safely used in environments where MRI scans are conducted without interference or safety concerns.
How is the Air Pressure Therapy System (VU-IPC4M) supplied, and what components are included?
The VU-IPC4M is supplied as a complete system, which includes the inflatable tube massager, tubing, and pressure control components. This ensures all necessary parts for operation are provided out-of-the-box for immediate clinical use.
Can the Air Pressure Therapy System (VU-IPC4M) be reused, or is it intended for single-use only?
The VU-IPC4M is designed for both single-use and reusable clinical settings, depending on the manufacturer’s guidelines. Clinicians should follow the manufacturer’s instructions for cleaning, disinfection, and maintenance to ensure safe reuse.
What regulatory pathways has the Air Pressure Therapy System (VU-IPC4M) undergone, and what does this mean for its use?
The VU-IPC4M has obtained FDA 510(k) clearance and complies with the Medical Device Regulation (MDR). This means it has been evaluated for safety and effectiveness by regulatory authorities, confirming its suitability for clinical use in markets where these approvals apply. The device is classified as a Class II medical device under FDA regulations, indicating a moderate level of regulatory oversight.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K233238 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xiamen Weiyou Intelligent Technology Co., Ltd
- FDA Applicant
- Xiamen Weiyou Intelligent Technology Co., Ltd.
Sources (2)
- FDA 510(k) K233238 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 28, 2026