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The extriCARE® 3600 Negative Pressure Wound Therapy System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed. The extriCARE® 3600 Negative Pressure Wound Therapy System is indicated for the following wound types: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafis.

The system consists of a vacuum pump, canister, tubing, NPWT bandage or NPWT Foam Kits. In operation, the device is attached via the tubing to a Negative Pressure Wound bandage or foam kits. Maximum pressure and continuous mode or intermittent mode selection are digitally programmable. The extriCARE 3600 pump can be sold alone or as a part of the extriCARE 3600 system with extriCARE bandages or foam kits. The extriCARE bandages are an all-in-one wound dressing; with no wound packing required which is cleared in the predicate K110078. The foam kit consists of Polyurethane foam, transparent film drape, paper ruler, Suction Bell with connecting (drainage) tube and clamp, which is included in this submission for review.

extriCARE® 2400 Negative Pressure Wound Therapy System is a portable, battery powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing.

extriCARE® Negative Pressure Wound Therapy Foot Dressing

The Cirona™ DVT Prevention Therapy Foot Garment is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, urologic, obstetric conditions and treatments.

The Cirona™ deep vein thrombosis prevention therapy foot garment is intended to be used with Devon Cirona™ 6100 deep vein thrombosis prevention system (K130571). The Cirona™ deep vein thrombosis prevention foot garment is a pair of single patient reusable soft compression garment(s) (sleeves), that consists of a brushed nylon outer material bonded to a foam inner liner. An inflatable polyvinylchloride (PVC) pressure bladder is encapsulated in an additional foam material. The patient contact material is polyurethane foam and the extension tubing set connects to the garment on one end through quick connectors and to the pump on the other end. It is intended to be used noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life threatening condition. The FDA cleared Cirona™ 6100 system (K130571) consists of a pump, a pair of single patient reusable soft compression garment(s) (sleeves), and the extension tubing set for calf and calf-thigh. This submission is for the new Cirona DVT Foot Garment which will be used in conjunction with the Cirona 6100 system. The device will alternatively inflate the two garments and mimic the natural walking pace in order to enhance circulation. The device supplied compression provides a 60-second automatically timed cycle consisting of an approximately 12-second inflation period followed by a 48-second period of relaxation. A pressure of 40mm Hg is used for all applications. This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting.

The Cirona™ 6100 system is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, urologic, obstetric conditions and treatments.

The Cirona™ 6100 deep vein thrombosis prevention system is a pneumatic compression device that noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life threatening condition. The Cirona'''' 6100 system consists of a pump, a pair of single patient reusable soft compression garment(s) (sleeves), and the extension tubing set for calf and calf-thigh. The device will alternatively inflate the two garments and mimic the natural walking pace in order to enhance circulation. The device supplied compression provides a 60-second automatically timed cycle consisting of an approximately 12-second inflation period followed by a 48-second period of relaxation. A pressure of 40mm Hg is used for both the calf and calf-thigh treatments. This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting.

The CircuFlow™ 5150 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions: - Lymphedema - - Venous stasis ulcers - - Venous insufficiency - - Peripheral edema - The device is intended for both home and hospital use.

The CircuFlow™ 5150 is a digitally controlled sequential pneumatic compression device designed to apply compression to a limb. The CircuFlow™ 5150 enables different treatment pressures and treatment times that should be used according to physician prescription. When activated, air flows into the garment chambers, and the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within in the first chamber can be programmed, with each successive chamber having its pressure be 7% less than the previous chamber.

The CircuFlow 5208 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions: - Lymphedema - Venous stasis ulcers - Venous insufficiency - Peripheral edema The device is intended for home and hospital use.

The CircuFlow 5208 is a digitally controlled sequential pneumatic compression device designed to apply compression to a limb. The CircuFlow 5208 enables different treatment pressures and treatment times that should be used according to physician prescription. When activated, air flows into garments chambers, the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within each chamber can be programmed and individual chambers can be skipped or the pressure decreased in the case of a wound.

The ArterioFlow 7500 is intended as an adjunctive therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes: - Amputations (minor) . - Angioplasty/stent failure . - Arteriopathic wounds . - Graft failure . - Intermittent claudication . - Ischemia . - Night Pain . - Rest Pain . - Small vessel disease . - Ulcers . The device is intended for home and hospital use.

The ArterioFlow 7500 is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complication of poor circulation, by increasing arterial blood flow through the application of bilateral or unilateral intermittent compression to the foot and calf. The device for consists of a pump, inflatable garments, and tubing. In operation, the device is attached via tubing to garments containing inflatable chambers applied externally and bilaterally over the feet and calves. Maximum pressure and treatment times are digitally programmable. Quick connector fitting on the tubing prevent accidental and incorrect orientations. Garments are available in anatomical designs including a single inflation chamber for the foot and a single inflation chamber for the calf. Garments are non-sterile, intended for single patient use and are intended to be applied over bandages or clean hosiery. Hook-and-loop fasteners allow for easy application and adopting a variety of sizes.

The CircuFlow 5200 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions: - Lymphedema - - -Venous stasis ulcers - Venous insufficiency - - * Peripheral edema The device is intended for home and hospital use.

The CircuFlow 5200 is a digitally controlled sequential pneumatic compression device designed to apply compression to a limb. The CircuFlow 5200 enables different treatment pressures and treatment times that should be used according to physician prescription. When activated, air flows into garments chambers, the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within each chamber can be programmed and individual chambers can be skipped or the pressure decreased in the case of a wound.

The CircuFlow 5100 Sequential Compression Device is a manual, sequential, pneumatic compression device, intended for the primary or adjunctive treatment of primary or secondary lymphedema. The device is also intended for the additional or alternate treatment of venous insufficiency, and chronic venous stasis ulcers associated with venous insufficiency, as well as general treatment of swelling of the extremities. The device is intended for home or hospital use.

The CircuFlow 5100 is a sequential pneumatic compression device designed to apply compression to a limb. The device is composed of two components: - Pneumatic manual pump - Limb sleeve or garment composes of 4 chambers The CircuFlow 5100 enables different treatment pressures (0-120mmHg) and treatment times (30 minutes to continue) that should be used according to physician prescription. When activated, air flows into chamber, the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within chambers are adjustable -pressure to chamber 1 is controlled by user-adjusted regulator on the pump. Pressure in chambers 2, 3 & 4 are individually lowered according to the default factory settings. A calibrated dial gauge displays pressure in the range of 0-200 mmHg. Garments are available in 8 sizes, and custom garments are available in variations from standard sizes.

The Devon AccuBP Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The device is non-sterile and disposable. It is available in neonatal, through adult sizes.

Per CFR 870.1120, a Blood Pressure Cuff is a device that has an inflatable bladder within, or integral to, an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with an appropriate measuring device to determine a subject's blood pressure. The Devon AccuBP Cuffs are Latex Free. The Devon AccuBP Cuff comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to an appropriate non-invasive blood pressure measurement system. The blood pressure cuffs contain no latex. Sizes include neonatal through large adult. Each cuff is packed in a sealed polyethylene (non-sterile) bag and each cuff is marked with the effective size range of limbs on which it may be used. Attached to the end of each PVC tube are a variety of connectors for use with most monitoring systems. The AccuBP Cuffs are available in the following configurations: Five sizes for Neonatal (Neonatal #1-#5) and eight sizes for (Infant, Child, Small Adult, Adult, Adult Long, Large Adult, Large Adult Long, and Thigh) Both Single Tube and Double Tube configuration are available for all size.