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510(k) Data Aggregation

    K Number
    K051964
    Device Name
    POWERNEB
    Manufacturer
    COMEDICA , INC.
    Date Cleared
    2005-12-01

    (134 days)

    Product Code
    NHJ
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMEDICA , INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PowerNeb® is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.
    Device Description
    The PowerNeb is a pneumatic, single-patient use device used to enhance secretion clearance, deliver aerosol, and recruit lung volumes. PowerNeb uses a fixed venture against a user-set orifice to create a continuous high frequency oscillation (CHFO) waveform at 180-220 breaths per minute (BPM). The PowerNeb can also deliver a continuous expiratory pressure (CPEP) when switched to CPEP mode. This device is pneumatic in operation and does not incorporate any electronic parts or software. This device is non-sterile, and is not intended to be sterilized by the user. The PowerNeb is packaged with a a small-volume nebulizer/mouthpiece, and a disposable manometer, each of which has been previously 510k cleared.
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