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510(k) Data Aggregation

    K Number
    K221058
    Device Name
    LungTrainer (MD2 & MD3)
    Manufacturer
    Lung Trainers, LLC
    Date Cleared
    2023-07-05

    (450 days)

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

    Lung Trainers, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lung Trainer device is intended to be used as (1) an expiratory breathing exerciser for respiratory muscles, and (2) to be used as an expiratory resistance device, providing positive expiratory pressure (PEP) to substitute for pursed lip breathing and to assist in mucus clearance. The LungTrainer device is intended for use in patients ages 12 years and up in a clinical or home use environment.
    Device Description
    Not Found
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