Phlebo Press DVT 603
by Mego Afek AC, Ltd. EUDAMED510(k)
Active
510(k) K142772
Overview
The Phlebo Press DVT 603 is a Sleeve, Limb, Compressible device designed to apply graduated pneumatic compression to the lower limbs. It is intended for use in preventing deep vein thrombosis (DVT) by improving venous return and reducing blood stasis through sequential or intermittent compression therapy.
This device operates via fully automatic pneumatic control, delivering adjustable pressures (45 mmHg for thigh-calf garments, 130 mmHg for foot garments) in single-chamber or four-chamber modes. Supplied as a reusable medical device, it requires proper maintenance and calibration to ensure functionality. Authorized under FDA 510K and MDR, the Phlebo Press DVT 603 is classified as a Class II device under regulation 870.5800 and is intended for clinical use in cardiovascular settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK142772 | Date16 Dec 2014 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- JOW
- FDA applicant
- Mego Afek AC , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5800
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Mego Afek AC, Ltd.
Questions
What is the primary purpose of the Phlebo Press DVT 603, and how does it work to achieve this goal?
The Phlebo Press DVT 603 is designed to prevent deep vein thrombosis (DVT) by applying graduated pneumatic compression to the lower limbs. It works through sequential or intermittent compression therapy, improving venous return and reducing blood stasis in the veins. The device uses fully automatic pneumatic control to deliver adjustable pressures—45 mmHg for thigh-calf garments and 130 mmHg for foot garments—in either single-chamber or four-chamber modes to enhance circulation.
Is the Phlebo Press DVT 603 a single-use or reusable device, and what maintenance is required?
The Phlebo Press DVT 603 is a reusable medical device, meaning it is intended for repeated use in clinical settings. Since it operates via pneumatic compression, it requires proper maintenance and calibration to ensure accurate pressure delivery and functionality over time. Regular servicing, as outlined in the manufacturer’s instructions, is essential to sustain performance.
What pressure settings does the Phlebo Press DVT 603 offer, and how are they applied?
The device provides two primary pressure settings: 45 mmHg for thigh-calf garments and 130 mmHg for foot garments. These pressures are delivered through single-chamber or four-chamber modes, allowing for customized compression therapy tailored to the patient’s lower limb anatomy. The automatic pneumatic control system adjusts pressures sequentially to optimize venous return.
How is the Phlebo Press DVT 603 regulated, and what classification does it hold?
The Phlebo Press DVT 603 is authorized under FDA 510K clearance and MDR (Medical Device Regulation). It is classified as a Class II device under the regulation number 870.5800, which pertains to sleeves and limb compression devices. This classification reflects its role in cardiovascular therapy for preventing DVT.