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

    RelieVRx

    K Number: K243417 · Decision Dec 4, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    30

    Basic Information

    Device Name
    RelieVRx
    K Number
    K243417
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5800
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AppliedVR
    Date Received
    November 4, 2024
    Decision Date
    December 4, 2024
    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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