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The Circul8 Pro Vascular Therapy System is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to: - · Aid in the prevention of DVT; - · Enhance blood circulation; - · Diminish post-operative pain and swelling; - · Reduce wound healing time; - · Aid in the treatment and healing of stasis dermatits, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs. The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

The Circul8 Pro Vascular Therapy System is a lightweight, portable, rechargeable battery powered prescription device. The device is intended to be used in the home or clinical setting by or under the direction of a medical professional by any patient needing venous return due to an increased risk from blood clots. The subject device is a modification of the predicate device in K193020, which includes: - modification of the plastic housing the electronically controlled air pump unit and solenoid valve, - relocation of the tactile touch control switch from the front of the housing to the housing, - introduction of LED display to replace the tricolored LED for ON, LOW BATTERY, CHARGE COMPLETED indications, and the blue LED for indicating a leak or low pressure alarm, - removal of the micro USB port for obtaining usage (patient compliance) data, - no longer labeling cuff as either left leg cuff or right leg cuff, - cuffs are filled to 55 mmHg pressure - introduces Night Mode, which minimizes light disturbances from the LEDs during patient resting times. - increased battery life. Both the subject device and predicate device utilize pneumatically controlled, single chamber cuffs actuated by an electronically controlled air pump unit and solenoid value of trol components are protectively housed in a plastic case that is permanently attached to the inflatable cuff.

CIRCUL8 Luxe, is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to: - · Aid in the prevention of DVT; - · Enhance blood circulation: - · Diminish post-operative pain and swelling: - · Reduce wound healing time; · Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs. The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

The CIRCUL8 Luxe DVT Prevention Device is an ambulatory, portable, light weight, prescriptive intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. The purpose of the CIRCUL8 Luxe is to aid in the prevention of Deep Vein Thrombosis (DVT) by helping to stimulate blood flow in the legs. This is accomplished by an electronically controlled pump delivering a set amount of air to the leg cuffs that, in turn, compress the calf or calves to aid blood flow out of the lower extremities. The pump will inflate each leg cuff to a pre-set pressure of 60mmHg (± 5 mmHg) and deflate once the pressure is reached. The cycles are repeated on each unit until the power is turned off. Internal rechargeable batteries (Li ion) allow the CIRCUL8 Luxe to be completely portable, thus preventing interruptions in treatment.