WoundPro Negative Pressure Wound Therapy System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150960 FDA 510(k)
- FDA Product Code
- OMP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4780 FDA 510(k)
- Regulation Number
- 878.4780 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The WoundPro Negative Pressure Wound Therapy System is a powered suction pump designed for negative pressure wound therapy. It functions as a control unit to provide negative pressure to a wound site to assist in the healing process.
This device is regulated under 21 CFR 878.4780 and has received FDA 510(k) clearance. It is designed as a portable unit for use in clinical or patient settings.
Frequently asked questions
What is the primary function of the WoundPro system?
The WoundPro is a powered suction pump designed to provide negative pressure to a wound site. This process is intended to assist in the wound healing process.
In what environments can the WoundPro be used?
The device is designed as a portable unit, allowing it to be used in both clinical settings and patient settings to provide therapy as needed.
Is the WoundPro system regulated?
Yes, the device is regulated under 21 CFR 878.4780 and has received FDA 510(k) clearance, which confirms it has been reviewed and cleared for use.
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. Sources consulted: WoundPro: Reliable, Powerful NPWT Wound Care Pump Vac - Pensar Medical, Negative Pressure Wound Therapy Devices | Pensar Medical, PDF Negative Pressure Wound Therapy Operator's Manual, WoundPro Negative Pressure Wound Therapy System Operator's Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150960 | Class II | Active |
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Manufacturer
- Manufacturer
- Pensar Medical, LLC
Sources (1)
- FDA 510(k) K150960 24 fields · synced Sep 26, 2026