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    K Number
    K130888
    Device Name
    SONOPULSE/ SONOPULSE III
    Manufacturer
    IBRAMED- INDUSTRIA BRAZILERIA DE EQUIPAMENTOS MEDI
    Date Cleared
    2014-01-09

    (286 days)

    Product Code
    IMI
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    IBRAMED- INDUSTRIA BRAZILERIA DE EQUIPAMENTOS MEDI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Therapeutic Ultrasound: - Pain relief - Reduction of muscle spasms - Localized increase in blood flow - Increase range of motion of contracted joints using heat and stretch techniques
    Device Description
    The Sonopulse III offers 1.1 and 3.3MHz ultrasound using a 7cm² transducer. The membrane panel provides both tactile and audio feedback when the buttons are pressed. A provides a through set-up routine for the operator. The display will show which treatment has been chosen and when the output is active. The Sonopulse offers 1.1 and 3.3MHz ultrasound using a 7cm² or 3cm² transducer. The membrane panel provides both tactile and audio feedback when the buttons are pressed. A provides a through set-up routine for the operator. The display will show which treatment has been chosen and when the output is active.
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