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The Venowave VW5 series of devices are prescriptive and induce improved vascular and lymphatic flow of the lower limbs. Very similar to the predicate device, the Venowave V W5 series of devices are intended to treat the following: - Management of the symptoms of post thrombotic syndrome (PTS) . - Prevention of deep vein thrombosis, (DVT) . - Prevention of primary thrombosis . - . Treatment of lymphedema - . Diminishing post-operative pain and swelling - . Treatment of leg swelling due to vascular insufficiency - . Treatment of varicose veins - Treatment of chronic venous insufficiency t - . Enhancing blood circulation - Treatment of intermittent claudication .

The Venowave VW5 is a series of compact, battery-operated peristaltic pumps that generate a wave-form motion. and when worn below the knee strapped firmly to the calf, result in compression of the calf and consequently an increased upward volumetric displacement of venous and lymph fluid. Each of the models within the family (VW5-6; VW5-10; VW5-20; and VW5-30) is distinguished by the maximum number of times the wave plate cycles each minute (6, 10, 20 and 30 cycles/minute respectively). Each model is also capable of operating at two speeds. Clinical preference to choose a specific frequency of motion for each specific patient based upon that patient's clinical symptoms, severity of disease, and perceived compliance with treatment has been the motivation for creating each model within the series. The optimum choice of model for each patient is the slowest device that achieves the desired therapeutic objective. The slower the device is, the quieter the operation and the longer the battery and mechanical life of the unit. Each model, however, may in fact be used interchangeably to treat patients suffering from a class of diseases that result from chronic venous insufficiency. The Venowave VW5 weighs about 260g, and has dimensions measuring roughly 190mm x 75mm x 30mm enabling one to wear it under loose clothing. It is designed to be packaged and sold as a prescription-only assembled device. The Venowave generates a mechanical wave which starts at the lower pivot point and travels to the upper pivot point, a distance of 14cm (wavelength) traveled for each cycle of the crank. The swept volume of blood or lymph fluid displaced upwards for each cycle is the product of the wavelength (14cm), the width of the wave sheet (7,5cm) and the depth of the wave (0.95cm) or approximately 0.1 L/cycle. Operating by way of a single rechargeable 1.5 V NiMh AA battery, this single-patient use device enables the user to receive treatment anywhere, while remaining active.