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510(k) Data Aggregation

    K Number
    K202186
    Device Name
    TrueRelief Device
    Manufacturer
    TrueRelief
    Date Cleared
    2021-03-23

    (231 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    TrueRelief

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TrueRelief Device is intended for use under the supervision of a Healthcare Professional. TrueRelief is intended for temporary symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
    Device Description
    The TrueRelief device is an AC power operated device that consists of three main components and associated power cables: the pulse generator, a primary probe and a secondary probe. The signal generator applies electromagnetic energy transcutaneously through the primary and secondary probes into painful tissue, similar to Transcutaneous Electrical Nerve Stimulation (TENS) device. The TrueRelief device uses a proprietary waveform with small voltage fluctuations to achieve pain relief.
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