Devon Medical Products Receives FDA 510(k) Clearance to Market its extriCARE® 3600 High-Flow Negative Pressure Wound Therapy (NPWT) Pump and Foam Wound Dressing Kit
KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Global medical device designer and manufacturer Devon Medical Products today announced substantial additions to its Negative Pressure Wound Therapy (NPWT) wound care product line after receiving Food & Drug Administration (FDA) 510(k) clearance to market its extriCARE® 3600 NPWT pump and foam dressing kit. View product details here.
“This regulatory approval is a significant step for Devon Medical Products as it opens the door for us to treat a broader range of wounds commonly found in institutional settings”
The extriCARE® 3600 NPWT pump and foam kit are intended for use on wounds with large amounts of exudate, including wounds of critical nature. The products were designed for use in acute care and post-acute care settings, as well as skilled nursing facilities. Features of the extriCARE® 3600 include a 24-hour continuous, rechargeable battery, a rotatable back-mount for securing the device to hospital bed rails and IV poles, simple pressure settings between 40-200mmHg of pressure, and various alarms signaling air leakage, low battery, and other errors. The device currently utilizes a 400cc disposable canister, and a 1,000cc canister is in development.
“This regulatory approval is a significant step for Devon Medical Products as it opens the door for us to treat a broader range of wounds commonly found in institutional settings,” says Chip Ross, president of Devon Medical Products. “We added this larger NPWT pump and a foam wound dressing kit to help complete our NPWT product line and provide wound care professionals with the technology they need to manage all types of wounds. We are proud to now offer a complete line of NPWT pumps, dressings, and accessories at a fraction of the cost of many of our competitors.”
Devon Medical Products is showcasing the extriCARE® 3600 pump and foam dressing kits at the 46th Annual Wound, Ostomy and Continence Nurses Society™ Conference (booth #754) in Nashville, Tennessee this week. Various clinical experts are on hand to demonstrate Devon Medical Products’ entire NPWT product line, including the portable extriCARE® 2400 and various-sized NPWT dressings, as well as its line of compression therapy products for the management of lymphedema.
About Devon Medical Products, Inc.
Devon Medical Products, Inc. (www.devonmedicalproducts.com) is an ISO 13485 medical device manufacturer, designer, and distributor. Since 2005, we have developed innovative and high-quality medical devices that are affordable for healthcare markets and patients worldwide. Our exclusive therapeutic devices treat and prevent various types of wounds and health complications. Our product line includes the extriCARE® Negative Pressure Wound Therapy (NPWT) System, the CircuFlow® compression therapy pump series for the management of lymphedema, the ArterioFlow® 7500 arterial compression pump for the prevention and treatment of ulcers related to diabetic foot and other arterial diseases, and the Cirona® 6100 Deep Vein Thrombosis (DVT) prevention pump. We are headquartered in King of Prussia, Pennsylvania, and have international offices staffed with bilingual engineers, product development teams, and regulatory experts.