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510(k) Data Aggregation

    K Number
    K242175
    Device Name
    XOD Diathermia Radiofrequency Device
    Manufacturer
    XOD Inc.
    Date Cleared
    2025-02-27

    (218 days)

    Product Code
    PBX
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    XOD Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XOD diathermia radiofrequency device is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The XOD device also is intended to provide a temporary reduction in the appearance of cellulite.
    Device Description
    The XOD diathermia radiofrequency device generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A fixed electrode is placed in contact with the patient and a handheld electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed, and RF therapy can be provided. The device can be operated in a resistive monopolar mode. The product consists of a portable power console with a color touchscreen, and accessories including resistive threaded electrodes, and a silicon return plate. The unit can be adjusted to provide various levels of treatment frequency ranging from 442kHz to 454MHz.
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