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510(k) Data Aggregation

    K Number
    K091557
    Device Name
    LUNG FLUTE THERAPEUTIC
    Manufacturer
    MEDICAL ACOUSTICS
    Date Cleared
    2010-01-04

    (222 days)

    Product Code
    BWF
    Regulation Number
    868.5690
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL ACOUSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lung Flute® Therapeutic is indicated for Positive Expiratory Pressure (PEP) Therapy.
    Device Description
    The Lung Flute® Therapeutic is shaped like a pipe or flute with a plastic mouthpiece at one end. A Mylar reed is attached inside a square hardened plastic tube that flairs on the end to increase the internal air mass, which provides acoustical impedance. When the patient exhales through the "flute-like" device, the reed inside the tube oscillates and acts in tandem with the rest of the device and the lung cavity itself to produce a sound frequency that approximates the resonance frequency of pulmonary secretions. The Lung Flute® Therapeutic facilitates mucus clearing by generating and delivering a specific low frequency sound that vibrates the airways and lung secretions, causing lung secretions to thin and become expelled.
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    K Number
    K060439
    Device Name
    LUNG FLUTE
    Manufacturer
    MEDICAL ACOUSTICS LLC
    Date Cleared
    2006-06-22

    (121 days)

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

    MEDICAL ACOUSTICS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LUNG FLUTE™ is indicated for the collection of sputum samples for laboratory analysis and pathologic examination.
    Device Description
    The LUNG FLUTE™ is shaped like a pipe or flute with a plastic mouthpiece at one end. A Mylar reed is attached inside a square hardened plastic tube that flairs on the end to increase the internal air mass, which provides acoustical impedance. When the patient exhales through the "flute-like" device, the reed inside the tube oscillates and acts in tandem with the rest of the device and the lung cavity itself to produce a sound frequency that approximates the resonance frequency of pulmonary secretions. The LUNG FLUTE™ facilitates mucus clearing by generating and delivering a specific low frequency sound that vibrates the airways and lung secretions, causing lung secretions to thin and become expelled.
    Ask a Question

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