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    K Number
    K992256
    Device Name
    FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01
    Manufacturer
    INTERCONTINENTAL NEW TECHNOLOGIES, INC.
    Date Cleared
    2000-01-11

    (189 days)

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

    INTERCONTINENTAL NEW TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is for use as a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT) in one device, for use by adults and children. The device is for single patient use, not for use on multiple patients.
    Device Description
    The breathing trainer includes an inner chamber, an outer chamber, a breathing tube, and a perforated bottom cap to the inner chamber. Four teaspoons of water (20 ml.) are placed in the outer chamber and the patient breaths in and out of the breathing tube. The training effect is caused by the added pressure of the water. US Patent Number 5,755,640.
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