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    K Number
    K052611
    Device Name
    ECP HEALTH SYSTEM, MODEL 2005
    Manufacturer
    ECP HEALTH INC.
    Date Cleared
    2006-04-26

    (216 days)

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

    ECP HEALTH INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the ECP Health System Model 2005 is for the treatment of patients with: (1). Stable or unstable angina pectoris. (2). Acute myocardial infarction (3). Cardiogenic shock (4). Congestive heart failure
    Device Description
    ECP Health System Model 2005 is a positive and negative pressure integrated, non-invasive medical device for performing external sequential counterpulsation. It is a microprocessor-controlled system that inflates and deflates three parts of air cuffs which compress vascular beds in the calves, lower thighs, and upper thighs /buttocks to achieve the desired therapy.
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