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510(k) Data Aggregation

    K Number
    K233364
    Device Name
    Axon Therapy
    Manufacturer
    NeuraLace Medical Inc.
    Date Cleared
    2024-01-10

    (100 days)

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

    NeuraLace Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Axon Therapy is intended to stimulate peripheral nerves for relief of chronic intractable pain, post-surgical pain and/or for relief of chronic painful diabetic peripheral neuropathy in the lower extremities. The Axon Therapy is for use on patients 18 and older.
    Device Description
    The Axon Therapy is a magnetic stimulator system that provides brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves and provide chronic nerve pain relief. The subject device is intended to be used in clinics such as pain management clinics and physical therapy clinics. The device consists of Magnetic Stimulation Coil, Liquid Cool Unit, and a Cart. The Axon Therapy includes a thermal shutdown feature which is activated once the inside temperature of the stimulation coil either: (A) reaches 45°C or (B) exceeds 41°C for a total of nine minutes during a 20-minute session.
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