LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K023016
    Device Name
    NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE
    Manufacturer
    NICORE EQUIPMENT & LEASING, INC.
    Date Cleared
    2002-12-04

    (85 days)

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

    **NICORE EQUIPMENT **& LEASING, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NICORE Model NCP-1 is used to provide external counterpulsation (ECP) therapy, and is indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock and acute myocardial infarction.
    Device Description
    The NICORE Model NCP-1 is a proprietary, non-invasive medical device for performing external, sequential counterpulsation. It is a microprocessor-controlled system that inflates and deflates three pairs of air cuffs which compress vascular beds in the muscles of the calves, thighs, and buttocks to achieve the desired therapy.
    Ask a Question
    K Number
    K980937
    Device Name
    NICORE MODEL ESP -1
    Manufacturer
    NICORE EQUIPMENT & LEASING, INC.
    Date Cleared
    2000-09-15

    (918 days)

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

    **NICORE EQUIPMENT **& LEASING, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stable Angina Pectoris
    Device Description
    The NICORE™ model ESP-1™ is a proprietary, non-invasive medical device for performing external, sequential counterpulsation. It is a microprocessor-controlled system that inflates and deflates three pairs of air cuffs which compress vascular beds in the calves, lower thighs, and upper thighs/buttocks to achieve the desired therapy.
    Ask a Question

    Page 1 of 1