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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
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LungTrainer (MD2 & MD3)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the "LungTrainer (MD2 & MD3)" device, outlining its regulation, product code, and indications for use. It primarily addresses administrative and regulatory compliance aspects rather than technical performance studies or acceptance criteria. Therefore, I cannot extract the requested information from this document.

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