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510(k) Data Aggregation

    K Number
    K051383
    Device Name
    THE INCOURAGE SYSTEM
    Manufacturer
    RESPIRATORY TECHNOLOGIES, INCORPORATED
    Date Cleared
    2005-06-17

    (21 days)

    Product Code
    BYI
    Regulation Number
    868.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESPIRATORY TECHNOLOGIES, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The inCourage™ System is indicated when external manipulation of the chest is the physician's treatment of choice for increasing the clearance of mucus in patients with pulmonary disorders. The system promotes airway clearance and improves bronchial drainage utilizing High Frequency Chest Wall Oscillation (HFCWO).
    Device Description
    The inCourage™ System is designed to assist in the loosening & eliminating of mucus from the lungs, utilizing high-frequency chest wall oscillation (HFCWO), when external manipulation of the chest is the physician's treatment of choice to increase the clearance of mucus. The primary components of The inCourage™ System include a blower, a motordriven valve, a power supply, and a control board that are connected to an inflatable iacket through interconnecting hoses. The blower-valve combination creates oscillating air that is delivered to the jacket via the interconnecting hoses. The result is a mythmic inflation and deflation of the jacket against the user's chest creating high-frequency chest wall oscillation, mobilization, and clearance of bronchial secretions.
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