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510(k) Data Aggregation

    K Number
    K103176
    Device Name
    FREQUENCER
    Manufacturer
    DYMEDSO INC.
    Date Cleared
    2011-01-26

    (90 days)

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

    DYMEDSO INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Frequencer™ V2 or V2x provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. This device is intended to be a component of chest physiotherapy by providing a convenient method of external thorax manipulation. It is indicated for patients having respiratory ailments which involve defective mucociliary clearance, as is typical in patients suffering from cystic fibrosis as well as chronic bronchitis, bronchiectasis, ciliary dyskinesia syndromes, asthma, muscular dystrophy, neuromuscular degenerative disorders, postoperative atelectasis and thoracic wall defects. Indications for this form of therapy are described in the Clinical Practice Guidelines for Postural Drainage Therapy of the American Association for Respiratory Care (AARC) published in 1991. This particular device provides a gentler, less painful form of therapy than the traditional "clapping" method of postural drainage therapy, allowing it to be used on patients who cannot be treated by clapping.
    Device Description
    The Frequencer™ V2 or V2x provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. It induces oscillatory sound waves in the chest by means of an electroacoustical power head (hereafter referred to as the "transducer") which is " placed externally on the patient's chest. The transducer is connected to a frequency generator which is capable of producing frequencies between 20 and 65 Hz. The transducer induces sound waves in the patient's chest which are effective in loosening mucus deposits. The model V2x uses disposable adapters with filters and is intended for use in multi-patient settings. The model V2 uses a permanent non-filtering adapter and is intended for single patient use.
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    K Number
    K100749
    Device Name
    FREQUENCER MODEL V2X
    Manufacturer
    DYMEDSO INC.
    Date Cleared
    2010-08-31

    (168 days)

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

    DYMEDSO INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Frequencer™ v2x provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. This device is intended to be a component of chest physiotherapy by providing a convenient method of external thorax manipulation. It is indicated for patients having respiratory ailments which involve defective mucociliary clearance, as is typical in patients suffering from cystic fibrosis as well as chronic bronchitis, bronchiectasis, ciliary dyskinesia syndromes, asthma, muscular dystrophy, neuromuscular degenerative disorders, postoperative atelectasis and thoracic wall defects. Indications for this form of therapy are described in the Clinical Practice Guidelines for Postural Drainage Therapy of the American Association for Respiratory Care (AARC) published in 1991. This particular device provides a gentler, less painful form of therapy than the traditional "clapping" method of postural drainage therapy, allowing it to be used on patients who cannot be treated by clapping. The Frequencer™ v2x is only intended for use in hospitals and clinics.
    Device Description
    The Frequencer™ v2x provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. It induces oscillatory sound waves in the chest by means of an electro-acoustical transducer (hereafter referred to as the "Power Head") which is placed externally on the patient's chest. The Power Head is connected to a frequency generator which is capable of producing frequencies between 20 and 65 Hz. The Power Head induces sound waves in the patient's chest which are effective in loosening mucus deposits. This model is intended for use in hospital and clinic settings only and disposable filters are available for multi-patient use.
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    K Number
    K063645
    Device Name
    FREQUENCER, MODEL 1001
    Manufacturer
    DYMEDSO INC.
    Date Cleared
    2007-03-15

    (98 days)

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

    DYMEDSO INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Frequencer™ provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. This device is intended to be a component of postural drainage therapy by providing a convenient method of external thorax manipulation. It is indicated for patients having respiratory ailments which involve defective mucociliary clearance, as is typical in patients suffering from cystic fibrosis as well as chronic bronchitis, bronchiectasis, ciliary dyskinesia syndromes, asthma. muscular dystrophy, neuromuscular degenerative disorders, post-operative atelectasis and thoracic wall defects. Indications for this form of therapy are described in the Clinical Practice Guidelines for Postural Drainage Therapy of the American Association for Respiratory Care (AARC) published in 1991. This particular device provides a gentler, less painful form of therapy than the traditional "clapping" method of postural drainage therapy, allowing it to be used on patients who cannot be treated by clapping.
    Device Description
    The Frequencer™ provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. It induces oscillatory sound waves in the chest by means of an electro-acoustical transducer (hereafter referred to as the "Power Head") which is placed externally on the patient's chest. The Power Head is connected to a frequency generator which is capable of producing frequencies between 20 and 100 Hz. The Power Head induces sound waves in the patient's chest which are effective in loosening mucus deposits.
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