Devon Medical Products Wins FDA 510(k) Clearance of Foam Wound Dressing Kit

Devon Medical Products Inc. has received U.S. Food & Drug Administration (FDA) 510(k) clearance for its extriCARE 2400 Negative Pressure Wound Therapy (NPWT) pump to operate with its foam dressing kit.

The extriCARE 2400 NPWT pump is a lightweight, portable and battery-powered device that works with Devon Medical Products’ patented anatomically fitted NPWT bandage dressings and new foam dressing kit. The negative pressure system works to remove wound exudates, infectious material, and tissue debris from the wound bed and bring blood to the wound, the company noted in a news release. The foam dressing kit utilizes a foam pad under an adhesive film that can be applied directly to the wound bed.

“With this FDA regulatory approval, it is a huge advancement for our extriCARE Negative Pressure Wound Therapy product line,” said Chip Ross, president of Devon Medical Products. “Our extriCARE pumps were designed with the patient in mind. We can now offer our customer a complete solution in Negative Pressure Wound Therapy for all care settings. Our system addresses a multitude of wounds and offers flexibly and choice with our pumps, canister and diverse dressing solutions.”

Devon Medical Products’ extriCARE pumps and dressings offer a simple, effective solution for NPWT in hospitals, long-term care facilities, and home health, according to Devon Medical. The extriCARE 2400 NPWT pump has a rechargeable battery, easy to operate display and settings, making the device simple yet effective for NPWT wound care. The extriCARE 3600 NPWT pumps have a 24-hour continuous, rechargeable battery, a rotatable back-mount for securing the device to hospital bed rails and IV poles, simple pressure settings, and various alarms signaling. The pump’s size and simple display does not lack on performance making it ideal for hospital and clinical settings. The extriCARE bandage, foot, and foam dressings round up availability to help treat all types of wounds.

Devon Medical Products is an ISO 13485 medical device manufacturer, designer, and distributor of therapeutic devices that treat and prevent various types of wounds and health complications. Its product line includes the extriCARE Negative Pressure Wound Therapy 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 prevention pump. The firm is  headquartered in King of Prussia, Pa.