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510(k) Data Aggregation

    K Number
    K203209
    Device Name
    AirPhysio Positive Expiratory Pressure (PEP) Device
    Manufacturer
    AirPhysio Pty Ltd
    Date Cleared
    2021-01-15

    (77 days)

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

    AirPhysio Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AirPhysio is indicated for use as a Positive Expiratory Pressure (PEP) Device for improving the clearance of mucus secretions from the airways. AirPhysio vibrates the airway walls to assist in loosening mucus and intermittently increases endobronchial pressure so that the airway patency can be maintained during exhalation, reducing the potential of mucus becoming trapped as it moves up the airways. The device may also be useful in the removal of mucus from patients who have chronic bronchitis or bronchiectasis and in conjunction with a medical need for positive expiratory pressure (PEP) therapy.
    Device Description
    AirPhysio is a small, handheld expiration resistance device, consisting of a hardened plastic mouthpiece at one end, a plastic cover with an opening at the other end, and a valve on the inside created by a high- density stainless-steel ball resting in a plastic conical cone. Exhalation through the device causes vibrations, assisting to loosen mucus from the airways. The resistance is increased by tilting the device. The subject device is provided non-sterile for reprocessing in a home environment and has no accessories or configuration options.
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