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510(k) Data Aggregation

    K Number
    K132988
    Device Name
    VITAL COUGH
    Manufacturer
    LUNG ASSIST, INC.
    Date Cleared
    2014-03-28

    (185 days)

    Product Code
    NHJ
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUNG ASSIST, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vital Cough is intended for use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. For use in a hospital, institutional setting, or home use given adequate training. For use on adult or pediatric patients.
    Device Description
    The device is an electromechanical software controlled device housed in a metal and polymer case. A touch screen displays outputs and receives commands from the user. The device develops positive and negative pressure through an adjustable blower. In inhale mode the lungs are inflated. The device rapidly shifts to providing negative pressure with the intended goal of rapidly deflating the lungs to stimulate an effective patient cough. A flutter feature developed by an oscillator butterfly valve may be activated during exhalation to assist in loosening and removing secretions.
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    K Number
    K120277
    Device Name
    VITAL COUGH
    Manufacturer
    LUNG ASSIST, INC.
    Date Cleared
    2012-09-12

    (226 days)

    Product Code
    NHJ
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUNG ASSIST, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vital Cough is intended for use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. For use in a hospital, institutional setting, or home use given adequate training. For use on adult or pediatric patients.
    Device Description
    The device is an electromechanical software controlled device housed in a metal and polymer case. A touch screen displays outputs and receives commands from the user. The device develops positive and negative pressure through an adjustable blower. In inhale mode the lungs are inflated. The device rapidly shifts to providing negative pressure with the intended goal of rapidly deflating the lungs to stimulate an effective patient cough.
    Ask a Question

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