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510(k) Data Aggregation
K Number
K150960Device Name
WoundPro Negative Pressure Wound Therapy System
Manufacturer
Date Cleared
2016-12-01
(601 days)
Product Code
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
PENSAR MEDICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The WoundPro Negative Pressure Wound Therapy System may promote wound healing, through the drainage and removal of infectious material and other fluids from the wound site, with continuous and/or, intermittent negative pressure. Patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts may benefit from the use of this device. The WoundPro is intended for use in a healthcare facility only.
Additional Wounds Indicated are:
- · Diabetic/Neuropathic ulcers
- · Pressure ulcers
- · Chronic wounds
- · Acute wounds
- · Dehisced wounds
Device Description
The WoundPro is part of a family of products offered by Pensar Medical LLC. The WoundPro is a powered suction pump that uses controlled negative pressure to a dressing and flange assembly through tubing.
The control unit incorporates a maintenance free brushless DC motor and is powered by a rechargeable battery power source. Optionally the unit can be connected to mains power using the included Medical Grade Switching power converter. The device is monitored by software and contains an alarm function with audio and visual prompts.
The WoundPro has a negative pressure setting range of 20mm to 200mmHg which is electronically monitored and controlled. The pump includes push button user interface controls and an electronic display with audible and visual alarm indicators.
The device can accommodate 300cc and 800cc canister sizes.
The unit can be operated on a countertop and has provisions for connection to IV poles, bedside rails, or footboard mounting.
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