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510(k) Data Aggregation

    K Number
    K030587
    Device Name
    EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP
    Manufacturer
    S-TCT HEALTH INC.
    Date Cleared
    2003-05-30

    (94 days)

    Product Code
    DRN
    Regulation Number
    870.5225
    Why did this record match?
    Applicant Name (Manufacturer) :

    S-TCT HEALTH INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    S-TCT Health, Inc.'s US-ECP Model IV is a non-invasive external counterpulsating device intended for use in the treatment of patients with stable angina pectoris, acute myocardial infarction and cardiogenic shock.
    Device Description
    The US-ECP is a painless, non-invasive medical device for performing external, sequential counterpulsation. Treatment is administered as the patient lies on the padded top of the device. The patient's calves, thighs, and buttocks are wrapped with specially designed adjustable pneumatic pressure cuffs, similar to blood pressure cuffs. Hoses connect the cuffs to an air pressure/vacuum pump enclosed in the device's base. The patient is also connected to an electrocardiogram to monitor the patient's heart rate. Once everything is properly in place, the device inflates and deflates the cuffs. The design of the cuffs permits significant pressure to be applied to the arteries and veins at relatively low air pressures. Timing for inflation and deflation is controlled electronically by running the patient's electrocardiogram signals through a microprocessor that monitors the entire treatment process. Each wave of pressure is electronically timed to the patient's heartbeat, so that the increased blood flow is delivered to the heart at the exact moment it is relaxing. When the patient's heart pumps again, pressure in the cuffs is released instantaneously. In short, the device pumps when the patient's heart is resting and releases pressure when the patient's heart is pumping. The intent of the treatment is to encourage cardiac circulation.
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