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510(k) Data Aggregation

    K Number
    K080299
    Device Name
    RESPIFIT S, MODEL RS-LR1001004
    Date Cleared
    2009-01-13

    (343 days)

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

    EUMEDICS MEDIZINTECHNIK UND MARKETING GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Respifit S is indicated for use as a training device used for conducting strength and endurance training by breathing into a patient module that contains an aperture. The purpose of this training is to improve inspiratory muscle strength and endurance. Training with the Respifit S can be performed in adults and patients with neuromuscular disease and cystic fibrosis in the hospital, clinic and home.
    Device Description
    The Respifit S is a portable device for training the respiratory muscles for strength and endurance.
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