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Intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated area in people who are in good health.

Bio Compression Systems' Sequential Circulators are powered inflatable tube massagers which consist of a segmented pneumatic sleeve ("garment") connected to a pneumatic compression pump ("pump"). The pump cyclically inflates the garment's segments ("chambers") in sequence from the distal end toward the trunk of the body. The sequential inflation of the garment simulates kneading and stroking of tissues with the hands, increasing circulation on the limb worn. The core components of the pump are the motor, air compressor, disc valves, and micro switch. The air compressor generates air flow into a stationary disc valve. The motor moves a rotating disc valve. The geometry of the disc valve directs air flow and cyclically triggers the micro switch. The pump is controlled by softkeys and an LED display (models SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL) or by a touch screen LCD (models SC-4004-DL, SC-4008-DL). The device uses the Predicate Device's garments.

The Bio Compression Systems' Sequential, pneumatic compression devices intended for either primary or adjunctive treatment of lymphedema, peripheral edema, venous insufficiency, and venous stasis ulcers. Sequential Circulators are also intended for the prophylaxis of deep vein thrombosis (DVT). Intended for use in a home or healthcare setting.

Bio Compression Systems' Sequential Circulators are sequential pneumatic compression device which consists of a segmented pneumatic compression sleeve ("qarment") connected to a pneumatic compression pump ("pump"). The pump cyclically inflates the garment's segments ("chambers") in sequence from the distal end toward the trunk of the body. The inflation of the garment compresses the limb on which it is worn, stimulating the movement of interstitial fluid and blood flow. The core components of the pump are the motor, air compressor, disc valves, and micro switch. The air compressor generates air flow into a stationary disc valve. The motor moves a rotating disc valve. The geometry of the disc valve directs air flow and cyclically triggers the micro switch. The pump is controlled by softkeys and an LED display (models SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL) or by a touch screen LCD (models SC-4004-DL, SC-4008-DL). The device uses the Predicate Device's garments.

VascuEase is a prescription device intended for the prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in prevention of venous stasis ulcers, aiding in the healing of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures. For use in home or hospital setting.

The VascuEase IC-1200-WH is a portable, rechargeable battery-powered, prescription device intended for home or hospital use to help prevent post-operative DVT in patients by stimulating blood flow as an aid in the prevention of DVT. The VascuEase IC-1200-WH (applicant device) provides intermittent pressure to the calf and thigh or foot through the use of inflatable garments. The cycle times and pressure are preset at the factory and cannot be changed by the user. The user interface consists of an On/Off button and two-color LED indicating operational status of the unit. The device consists of a pump. inflatable garments, and interconnection tubing. The pump air compressor is capable of no more than 80 mmHg maximum pressure and has pre-set inflate/deflate cycle times. Default pressure and timing is pre-set at the factory to 50 mmHz. with a cycle of 15 seconds on and 45 seconds off, which is consistent with the majority of indications prescribed. The garment consists of a discrete inflatable chamber, attached to the pump via interconnection tubing and Velcro. The garment is applied externally over the affected limb(s); unilateral or bilateral treatment can be applied. The garments are supplied non-sterile and are intended for single patient use.

The Bio Compression Systems Sequential Circulator SC-2004FC-OC with associated garments is a 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 for swelling of the extremities. The device is intended for home or hospital use.

The Bio Compression Systems, Inc. SC-2004FC-OC Sequential Circulator is a pneumatic compression device ('pump') with associated compressible garment sleeves. The pump is manually adjusted by the user to produce air pressure to inflate and deflate segmented inflatable chambers of garment sleeves. The garment sleeves are externally applied over affected extremities. The pumps consist of compressors capable of producing a maximum pressure of 80 mmHg and provide graduated or gradient pressurization to the chambers of the garments. The sequential inflation is applied distally to proximally with distal chambers inflated to a greater pressure than proximal ones. As each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all of the chambers are inflated, they are then simultaneously released and the cycle repeats. The user can adjust the Pressure Knob on the front of the device for desired pressure. Associated garments are available in a variety of standard sizes.

The Bio Compression Systems Sequential Circulator SC-2008-OC/Sequential Circulator SC-2004-OC with associated garments are sequential, pneumatic compression devices intended for the primary or adjunctive treatment of primary or secondary lymphedema. The devices are 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 for swelling of the extremities. The devices are intended for home or hospital use.

The Bio Compression Systems, Inc. SC-2004-OC Sequential Circulator and SC-2008-OC Sequential Circulator, are pneumatic compression devices ('pumps') with associated compressible garment sleeves. The pumps are manually adjusted by the user to produce air pressure to inflate and deflate segmented inflatable chambers of garment sleeves. The garment sleeves are externally applied over affected extremities. The pumps consist of compressors capable of producing a maximum pressure of 80 mmHg and provide graduated or gradient pressurization to the chambers of the garments. The sequential inflation is applied distally to proximally with distal chambers inflated to a greater pressure than proximal ones. As each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all of the chambers are inflated, they are then simultaneously released and the cycle repeats. The user can adjust the Pressure Knob on the front of the device for desired pressure. Associated garments are available in a variety of standard sizes. The pumps can operate unilaterally and bilaterally as needed.

The Bio Compression Systems' SC-3008-DL, SC-3004-DL, SC-3004FC-DL and SC-2008-DL pumps and associated garments are sequential, pneumatic compression devices intended for the primary or adjunctive treatment of primary or secondary lymphedema. These devices are 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 for swelling of the extremities. The devices are intended for home or hospital use.

The devices consist of AC-powered pumps and inflatable garments connected by flexible tubing. The pumps consist of a compressor capable of a maximum pressure of 150 mmHg, a rotating disc valve driven by a motor and a digital pressure sensor, housed in durable plastic, Moving parts are not accessible to the user. The garments consist of four (SC-3004-DL and SC-3004FC-DL) or eight (SC-2008-DL and SC-3008-DL) discrete inflatable chambers, attached to the pump via tubing, and are applied externally over the affected limb or torso. Unilateral or bilateral limb treatment can be applied. Unique connector fittings on the tubing prevent accidental and incorrect pump/garment combinations or use with garments or sleeves from other manufacturers. The system provides gradient pressurization to the chambers, i.e., sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones. As 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, the pressure is released in all chambers simultaneously, and the cycle repeats. The SC-3004-DL provides a 90-second inflation/deflation cycle, while the SC-3008-DL, SC-2008-DL and SC-3004FC-DL models provide 50-second cycles. The SC-3004FC-DL model is "fast cycle" and use the faster (8-chamber device) motor to turn the valve, providing faster cycle times for the four-chamber models. Operating pressure is 30 to 120 mmHg. Pressure is pre-set at the factory to 60 mmHg (distal) with a decreasing distal-to-proximal gradient of 1 mmHg per chamber. The compressor is capable of no more than 150 mmHg pressure, making the device intrinsically safe. Pressure can be adjusted up or down in increments of 1 mmHg with the UP and DOWN pressure button arrows. The pressure is regulated by a digital pressure sensor that turns the air compressor pump on and off according to the pump pressure setting, and an LED panel displays the set pressure and displays "0" during the deflation cycle. In the SC-2008-DL device, the UP and DOWN pressure buttons allow the user to change the pressure in the distal chamber, and the decreasing 1 mmHg/chamber gradient is maintained throughout the remaining chambers. The SC-3004-DL. SC-3004FC-DL and SC-3008-DL models have the same feature but additionally provide a means to change the individual chamber pressures in the gradient. The software prevents reverse gradient adjustments. When the garments are inflated, they compress the limb and help to move lymph away from the extremities and/or torso so it can be eliminated by the body. Garments are available in sizes to accommodate varying limb lengths and girth, and custom garments can be provided. The SC-3004-DL and SC-3004FC-DL systems have four-chamber garments, and the SC-2008-DL and SC-3008-DL systems have eight-chamber garments. Garments are supplied non-sterile, intended for single patient use, and are intended to be applied over bandages or clean hosiery. Velcro fasteners support garment application. Instructions are provided for the patient to attach the garments and perform therapy at home after a physician has prescribed treatment and the patient has been oriented and educated on proper use of the device. The user interface consists of UP and DOWN pressure adjustment arrows (buttons). All controls and measurement functions are integrated into the PCB assembly. When turned on, the timer sends a signal to start the pump and the valve motor. The pump sends air through the valve, which turns and sends air to the output ports, filling each garment chamber sequentially. As the valve continues to rotate the air is released from all chambers at once and the garment deflates. The cycle repeats every 90 seconds for the SC-3004-DL or every 50 seconds for the SC-2008-DL, SC-3008-DL and 3004FC-DL. Treatment duration is prescribed by the physician, and typically is two one-hour sessions per day.

When used with GID-3045-T Calf/Thigh or GID-3045-K Calf garments: - Intended for prophylaxis of deep vein thrombosis When used with GI-3045-F Foot Garments - Intended for prophylaxis of deep vein thrombosis - Enhancement of venous and arterial circulation - Prevention of venous stasis ulcers - Reduction of acute or chronic edema - Reduction of lower limb pain due to surgery or trauma - Reduction of compartment pressures

The IC-1545-DL Multi-Flo DVT Combo (applicant device) provides intermittent pressure to the calf and thigh or foot through the use of inflatable garments. The applicant device is a digitally-controlled version of the predicate device, with identical specifications. There is no change in fundamental technology and no change in intended use from the predicate device, K610857. The digital modification provides identical call/thigh (KT) and foot (F) timing and pressure options as the predicate and it has the same intended use as the predicate, including prophylaxis of deep vein thrombosis (DVT) and enhancing venous and arterial circulation. Tubing connector design variations prevent interchangeability of garments between the models. The user interface consists of a soft keypad where the predicate has a rocker on/off switch and a pressure adjustment knob. The analogue pressure gauge and regulator have been removed, making the applicant unit 27% smaller and 47% lighter than the predicate, and both are designed to hang on bedrails for easy access to bed-ridden patients. The device consists of a pump, inflatable garments, and interconnection tubing. The pump compressor is capable of no more than 150 mmHg maximum pressure and has pre-set inflate/deflate cycle times. Default pressure and timing is pre-set at the factory to 50 mmHg, with a cycle of 15 seconds on and 45 seconds off (KT option). This is consistent with the majority of indications prescribed. All controls and measurement functions are contained in the PCB assembly. When turned on, the timer sends a signal to start the pump sends air to the output ports, filling the garments with air. A digital pressure sensor maintains the pressure by turning the compression pump on and off. After 45 seconds, the timer stops the pump and opens a valve to deflate the garnents and 15 seconds later the cycle repeats. In order to achieve its intended use, the device is attached via interconnecting tubing to sleeves (garments) applied externally and bilaterally over the lower extremities. The garments contain discrete, interconnected and segmented inflatable chambers. The pump provides intermittent, rapid impulse pressurization to the chambers. The pressure can be adjusted up or down in increments of I mmHg with up and down soft key arrows, and an alarm is provided for low/no pressure. When the garnents are inflated, they compress the veins in the calf, expelling blood from the leg, overcoming blood stasis and promoting circulation. The device runs continuously until turned off. An LED display shows the pressure setting during the inflation cycle and "0" during the deflation cycle. Pressure setting can be changed by the user, while timing cycles can be changed with special instructions provided to the distributor. An alarm will alert the user if inflation pressures do not exceed 30 mmHg. All garments are supplied non-sterile and for single patient use. DVT prophylaxis garments are available in a total of three anatomical configurations as indicated to the calves or the calves and the thighs (KT) and the feet (F).

The IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System is intended as an adjunct 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 IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System (IC-BAP-DL, applicant device) is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation by increasing arterial blood flow through the application of bilateral or unilateral intermittent compression to the foot and calf. The device consists of an AC-powered pump, inflatable garments, and interconnection tubing. In operation, the device is attached via the interconnection tubing to sleeves or garments containing discrete inflatable chambers, which are applied externally and bilaterally over the feet and calves. Unique connector fittings on the interconnect tubing prevent accidental and incorrect pump/garment/anatomy combinations or use with garments or sleeves from other manufacturers. The pump design provides intermittent, rapid impulse pressurization to the chambers. Inflation and deflation cvcles are requlated by a two-section valve, turned by the valve motor at three rpm. The pressure is regulated by a digital pressure sensor that turns the air compressor pump on and off using information from the pressure sensor. When the garments are inflated. they compress the blood vessels in the foot and calf, expelling blood from the leg, overcoming blood stasis and promoting circulation. Pressure is pre-set at the factory to 120 mmHg, and the compressor is capable of no more pressure than 150 mmHq, making the device intrinsically safe. Pressure can be adjusted up or down in increments of 1 mmHg with the UP/DOWN soft key arrows. An LED panel displays the set pressure and display "0" during the deflation cycle. Foot/calf garments are connected and are available in a range of sizes. The garments contain discrete, interconnected and segmented inflatable chambers, providing a single inflation chamber for the foot and two inflation chambers for the calf. Garments are supplied nonsterile, intended for single patient use, and are intended to be applied over bandages or clean hosiery. Velcro fasteners support garment application. The device is intended for home use. and instructions are provided for the patient to attach the garments and perform therapy after physician prescription and patient orientation and education. The user interface consists of a soft keypad and UP/DOWN pressure adjustment soft kev arrows. All controls and measurement functions are contained in the PCB assembly. When turned on, the timer sends a signal to start the pump and the valve motor. The pump sends air through the 2-section valve, which turns and sends air to the two bilateral output ports, filling first the foot and then the calf garments. As the valve continues to rotate the air is released from all chambers at once and the garments deflate. The cvcle repeats three times per minute and default treatment time is one hour, controlled by an internal timer on the PCB.

The 2004-0C and 2008-0C Massage Systems are powered inflatable tube massagers intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. The devices are intended for home use by people who are in good health.

The device consists of an air compressor with manually adjustable pressure settings (i.e., the user manually adjusts the pressure, while the inflate/deflate cycle times remain constant) and a sleeve or garment containing four (2004-OC) or eight (2008-OC) discrete, segmented inflatable chambers externally applied to the limb. The pump consists of a compressor capable of a maximum pressure of 150 mmHg, and provides graduated, or gradient, pressurization to the chambers (e.g., sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). An in-line check valve limits the output pressure to 80 mmHg, and a calibrated dial gauge displays pressure in the range of 0-125 mmHq. As 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. Pressures within the distal chambers have a default value set at the factory (60 mmHg distal), and can be adjusted by the user to distal pressures between 30 mmHg and 80 mmHg. Pressures decrease by 5 mmHg in each proximally sequential chamber. Garments are available in sizes to accommodate varying limb lengths. An adapter is available to support bilateral treatment.

The BioArterial Plus Arterial Blood Flow Enhancement System is intended as an adjunct 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 BioArterial Plus Arterial Blood Flow Enhancement System is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation, by increasing arterial blood flow through the application of bilateral or unilateral intermittent compression to the foot and calf. The AC-powered device for consists of a pump, inflatable garments, and interconnection tubina. In operation, the device is attached via interconnect tubina to sleeves or garments containing discrete inflatable chambers applied externally and bilaterally over the feet and calves. Unique connector fittings on the interconnect tubing prevent accidental and incorrect pump/garment/anatomy combinations. Garments are available in a unique anatomical configuration, providing a single inflation chamber for the foot, and a single inflation chamber for the calf. Garments are supplied non-sterile, intended for single patient use, and are intended to be applied over bandages or clean hosiery. Hook-and-loop fasteners support a wide range of anatomy sizes. The device is intended for home use.