BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cranial Electrotherapy Stimulator To Treat Depression

    PMA: P230024 · Decision Dec 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Cranial Electrotherapy Stimulator To Treat Depression
    Trade Name
    Flow FL-100
    PMA Number
    P230024
    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 8, 2025
    Date Received
    August 7, 2023
    Expedited Review
    N

    Advisory Committee Statement

    FL-100 is intended for the treatment of moderate to severe major depressive disorder in the current episode, either as monotherapy or as an adjunctive treatment, in patients 18 years and older who are not considered treatment refractory to medication.

    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