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

    VRNT

    K Number: K254004 · Decision Apr 10, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    116

    Basic Information

    Device Name
    VRNT
    K Number
    K254004
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5800
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cognifisense, Inc.
    Date Received
    December 15, 2025
    Decision Date
    April 10, 2026
    Product Code
    QRA
    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
    QRA Virtual Reality Behavioral Therapy Device For Pain Relief

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