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    K Number
    K121123
    Device Name
    BIOFUSIONARY BEBE
    Manufacturer
    ROCKY MOUNTAIN BIOSYSTEMS, INC.
    Date Cleared
    2014-03-10

    (696 days)

    Product Code
    IMJ
    Regulation Number
    890.5290
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROCKY MOUNTAIN BIOSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biofusionary Bebe System is indicated to be used to generate deep heat within body tissues for treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
    Device Description
    The Biofusionary Bebe is used for diathermic heating of tissue. The Biofusionary Bebe hand piece tip is comprised of a coil shaped antenna which directs the flow of current parallel to the tissue surface, without contacting the tissue surface, thereby directing the magnetic component of the electromagnetic energy into tissue to result in the formation of eddy currents in tissue. These eddy currents encounter resistance, leading to localized heating.
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