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510(k) Data Aggregation

    K Number
    K073079
    Device Name
    THUMPER, MODEL: 1008
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Date Cleared
    2008-02-14

    (106 days)

    Product Code
    DRM
    Regulation Number
    870.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICHIGAN INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used to perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.
    Device Description
    The Thumper® Model 1008 is a pneumatically-powered, electronically controlled external cardiac compressor used on adult patients in a state of clinical death and in immediate need of respiratory and circulatory support. The Thumper® Model 1008 uses a gas-powered piston assembly with a massager pad and associated backboard to perform the function of a rescuer pressing on the patient's chest with his or her hands. A built-in ventilator that is compatible with a facemask or advanced airway replaces the rescuer's mouth-to-mouth breathing for the patient. The action of the piston and the action of the associated ventilator have been designed to perform mechanical Cardiopulmonary Resuscitation ("CPR") according to contemporary American Heart Association ("AHA") CPR guidelines for manual CPR. The Thumper® Model 1008 delivers standard AHA compliant CPR in two modes. The first is a 30:2 compression-ventilation ratio with a compression duration that is 50% of the cycle length at a rate of 100 compressions per minute. The second is a continuous compressions mode having a compression duration that is 50% of the cycle length at a rate of 100 compressions per minute with nine asynchronous breaths per minute.
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    K Number
    K972525
    Device Name
    THUMPER
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Date Cleared
    1997-10-02

    (87 days)

    Product Code
    DRM
    Regulation Number
    870.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICHIGAN INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used to perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.
    Device Description
    The Thumper® Model 1007 is a pneumatically powered external cardiac compressor used on a patient in a state of clinical death and in immediate need of respiratory and circulatory support. The Thumper® Model 1007 uses a gas powered piston assembly with a massager pad and associated backboard to perform the function of a rescuer pressing on the patient's chest with his or her hands. A built-in ventilator to replaces the rescuer's mouth to mouth breathing for the patient. The action of the piston and the action of the associated ventilator have been designed to perform mechanical CPR according to contemporary American Heart Association (AHA) CPR guidelines for manual CPR. The Thumper® Model 1007 delivers standard CPR in a 5:1 compression-ventilation ratio with a compression duration that is 50% of the cycle length at a rate of 90 compressions per minute.
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    K Number
    K962237
    Device Name
    THUMPER CARDIOPULMONARY RESUSCITATOR
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Date Cleared
    1996-09-05

    (86 days)

    Product Code
    DRM
    Regulation Number
    870.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICHIGAN INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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