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510(k) Data Aggregation

    K Number
    K220122
    Device Name
    APEX 6
    Manufacturer
    RF Innovations, Inc
    Date Cleared
    2023-03-15

    (421 days)

    Product Code
    GXD
    Regulation Number
    882.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    RF Innovations, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for use for lesioning of neural tissue and for pain management. It is indicated for use in the peripheral nervous system. The APEX 6 is to be used with LCCS electrodes and cannulae and Conmed Thermogard Dispersive Electrodes.
    Device Description
    The RF Innovations APEX 6 is a desktop RF lesioning generator which is used for the lesioning of neural tissue. The APEX 6 is a multi-lesioning, 6 channel portable generator that can provide continuous or pulsed RF output at 460 kHz, and monopolar or dual electrode modes. The device includes sensory and motor stimulation functions to fine tune electrode placement for procedures. Based on performance testing the device is designed to connect to LCCS FDA cleared lesioning probes which are inserted into patients for lesioning of neural tissue during medical procedures. Device features include a touch screen monitor incorporating microprocessor and graphics display for user interface as well as self-diagnostics, calibration checks, and recordkeeping functions.
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