BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Axon Therapy

    K Number: K210021 · Decision Jun 11, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    158

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    Basic Information

    Device Name
    Axon Therapy
    K Number
    K210021
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neuralace Medical, Inc.
    Date Received
    January 4, 2021
    Decision Date
    June 11, 2021
    Product Code
    QPL
    Advisory Committee
    Neurology
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QPL Electromagnetic Stimulator, Pain Relief

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    Other Clearances by Neuralace Medical, Inc.

    K Number Device Name
    K233364 Axon Therapy