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510(k) Data Aggregation

    K Number
    K964425
    Device Name
    A-V IMPULSE SYSTEM MODEL 6060
    Manufacturer
    POWELL,GOLDSTEIN,FRAZER & MURPHY
    Date Cleared
    1997-07-28

    (265 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    **POWELL,GOLDSTEIN,FRAZER **& MURPHY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Comparison of Indications for Lower Extremity: Reduces acute edema, such as elevated compartment pressures, edema secondary to trauma and/or surgical procedures, post-bypass graft edema, post-operative edema secondary to venous ligation or venous stripping and edema secondary to sprains, strains and sports related injuries of the lower extremity. Reduces chronic edema. Assists in treating patients at risk for deep vein thrombosis (DVT) and pulmonary embolism (PE), including providing pre-, intra, and post-operative prophylaxis for DVT and PE. Relieves circulatory disorders secondary to diminished blood flow, such as ischemia secondary to peripheral vascular disease. Assists healing of cutaneous ulcers. Relieves pain, increases range of motion and limb mobility, and expedites return of function following trauma or surgery. Treats venous stasis, venous insufficiency and varicose veins. Reduces lymphedema, including lymphedema secondary to trauma and/or surgery and reduces or controls chronic lymphedema, including post-paralytic lymphedema due to stroke or spinal cord injury. Comparison of Indications for Upper Extremity: Reduces acute edema, such as elevated compartment pressures, edema secondary to trauma and/or surgical procedures, and edema secondary to sprains, strains and other sports related injuries of the upper extremity. Reduces chronic edema. Relieves circulatory disorders secondary to diminished blood flow, such as ischemia secondary to peripheral vascular disease. Relieves pain, increases range of motion and limb mobility, and expedites return of function following trauma or surgery. Reduces lymphedema, including lymphedema secondary to trauma and/or surgery, post-mastectomy lymphedema, and reduces or controls chronic lymphedema including post-paralytic lymphedema due to stroke or spinal cord injury.
    Device Description
    The A-V Impulse System Model 6060 (AVIS 6060) is designed to stimulate the natural pumping action of a patient's venous plexus system located in the sole of the foot. During the normal weightbearing phase of ambulation, blood is forcibly emptied from a plexus of veins in the sole of the foot into the deep and high pressure veins of the calf and thigh. This internal pump propels the blood up the leg and back to the heart. The A VIS 6060 foot pump mimics this natural physiological process for patients who are confined to the bed or are otherwise unable to walk normally due to trauma, surgery or pathology. A similar pumping mechanism exists within the palm of the hand. There is a system of looping veins located near the metacarpo-phalangeal joints of the hand. Flexion of these joints triggers an internal pumping process that propels the blood into the deep and/or superficial veins of the arm and back to the heart. Besides flexing the fingers, increasing the tissue tension on the dorsum of the hand can trigger this pumping action. Either way, activation of the internal pump is followed by post-compression hyperaemia during which the venous plexus refills with blood.
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