BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cranial Electrotherapy Stimulator To Treat Depression

    PMA: P250010 · Decision Dec 31, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Cranial Electrotherapy Stimulator To Treat Depression
    Trade Name
    Proliv™Rx System
    PMA Number
    P250010
    Device Class
    FDA Class 3
    Product Code
    JXK
    Generic Name
    Cranial electrotherapy stimulator to treat depression
    Regulation Number
    882.5800
    Medical Specialty
    Neurology
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 31, 2025
    Date Received
    March 26, 2025
    Expedited Review
    N

    Advisory Committee Statement

    The Proliv™Rx System provides focal external Combined Occipital and Trigeminal Afferent Stimulation (eCOT-AS) treatment. It is intended as an adjunctive treatment for Major Depressive Disorder (MDD) in adults who failed to achieve satisfactory improvement from at least one previous antidepressant medication, for use at home or in clinic. It is a prescription-only device.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JXK Cranial Electrotherapy Stimulator To Treat Depression