Air Pressure Therapy System VU-IPC04
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Identity
- Device Name
- Air Pressure Therapy System EUDAMED
- Model / Reference
- VU-IPC04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971234470553 EUDAMED
- Basic UDI-DI
- 697123447VU-IPC047R EUDAMED
- EMDN Code
- Z120607 PNEUMATIC COMPRESSION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Air Pressure Therapy System VU-IPC04 is a Continuous Passive Motion Device (Nomenclature Code: Z120607) designed to apply controlled pneumatic pressure to joints or limbs. It facilitates joint mobility and tissue healing by delivering sequential compression cycles, reducing stiffness and promoting circulation in rehabilitation settings. The device is classified as Class IIa and is intended for active use in physical medicine applications.
This system is non-sterile, non-reusable, and non-implantable, supplied as a single-use device with active components. It is MRI-unsafe and must be stored in accordance with manufacturer instructions to preserve functionality. The device holds FDA 510(k) clearance and MDR compliance, with regulatory oversight by Sungo Cert GmbH (DE-AR-000010869). The unique device identifier (UDI) is 697123447VU-IPC047R, ensuring traceability and compliance with global medical device regulations.
Frequently asked questions
What is the primary purpose of the Air Pressure Therapy System VU-IPC04 and how does it benefit patients in clinical settings?
The Air Pressure Therapy System VU-IPC04 is a Continuous Passive Motion Device designed to apply controlled pneumatic pressure to joints or limbs. It helps improve joint mobility and tissue healing by delivering sequential compression cycles, which reduces stiffness and promotes circulation—particularly useful in physical medicine and rehabilitation settings.
Is the Air Pressure Therapy System VU-IPC04 reusable or single-use, and what does this mean for clinical workflows?
The device is explicitly labeled as non-reusable and intended for single-use only. This means each unit is meant to be used once per patient, reducing infection risks and ensuring consistent performance without the need for reprocessing or maintenance between uses.
Can this device be used in an MRI environment, and if not, what precautions should clinicians take?
The Air Pressure Therapy System VU-IPC04 is classified as MRI-unsafe, meaning it should never be placed in an MRI scanner or brought into the MRI environment. Clinicians must ensure the device is removed from the patient and stored away from MRI areas to avoid interference or safety hazards.
What regulatory approvals does the Air Pressure Therapy System VU-IPC04 hold, and how does this affect its use in different markets?
The device holds FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR), with oversight from Sungo Cert GmbH (DE-AR-000010869). This means it is legally marketable in the U.S. and EU under these regulatory frameworks, though clinicians should verify local compliance requirements before use.
How should the Air Pressure Therapy System VU-IPC04 be stored to maintain its functionality and safety?
The device must be stored according to the manufacturer’s instructions to preserve its functionality. Since it is non-sterile and non-reusable, storage should follow general medical device guidelines—protected from moisture, extreme temperatures, and physical damage—to ensure reliable operation when needed for patient treatment.
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
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210967 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K243320 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K201935 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K243791 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697123447VU-IPC047R | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xiamen Weiyou Intelligent Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000028653
- FDA Applicant
- Xiamen Weiyou Intelligent Technology Co., Ltd.
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED 5fbc510a-394f-4182-a508-0b29ab0c7baf 85 fields · synced Oct 6, 2026
- FDA 510(k) K210967 1 fields · synced May 18, 2026