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The NormaTec PCD is intended to be used to apply pressure to the extremities. The NormaTec PCD is indicated for use in the treatment of: Lymphedema and other edematous conditions, including Congenital lymphedema (Millroy's disease, lymphedema praecox, and lymphedema tarda) Post-mastectomy lymphedema Post-infection lymphedema Post-traumatic lymphedema Post-surgical lymphedema Post-radiation-treatment lymphedema Venous insufficiency Venous stasis ulceration and the prevention of: Deep Vein Thrombosis

The NormaTec PCD is substantially equivalent to its predicates because it has the same intended use and very similar technological characteristics. Both NormaTec's PCD and its predicates are intended to apply pressure to the extremities to treat edematous states like lymphedema, and to prevent deep vein thrombosis. NormaTec's PCD has very similar components as its predicate devices and very similar principles of operation. Each device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the sleeve, control of pressure applied cyclically and simultaneous treatment of two limbs, if necessary. Like the predicates, pressure is pulsed to the affected limb for a specified period of time, followed by a rest period, according to the physician's prescription.