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510(k) Data Aggregation

    K Number
    K121170
    Device Name
    RESIN 11
    Manufacturer
    Date Cleared
    2012-07-13

    (87 days)

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

    RESPINNOVATION SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RespIn11 is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy' (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the RespIn11 is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.
    Device Description
    RespIn11 is a medical device developed for an effective therapy of airway obstruction conditions. The device is made up of a jacket connected to a vibration/pulsation generator where the pulsations are obtained by the pressure differences of a multistage blower. These pulsations are transmitted to the subject's chest through an air pressure piston system specially designed and inserted into the front and rear cavities of the vest provided. The compression then release cycle on the chest wall generates a differential air speed in the bronchial airway in the lungs. This produces a shearing effect which pulls the mucus off the bronchial airway walls and to then be moved through mucociliary action into the larger upper airways to then be eliminated naturally through coughing or if necessary by external suction. This respiratory therapy is called HFCWO (High Frequency Chest Wall Oscillation).
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