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

    EaseVRx

    K Number: DEN210014 · Decision Nov 16, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    231

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    EaseVRx
    K Number
    DEN210014
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    890.5800
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Appliedvr, Inc.
    Date Received
    March 30, 2021
    Decision Date
    November 16, 2021
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QRA), ordered by most recent decision date.

    VRNT

    FDA 510(k)
    FDA Class 2 ·Neurology

    RelieVRx (Pico G3)

    FDA 510(k)
    FDA Class 2 ·Neurology

    RelieVRx

    FDA 510(k)
    FDA Class 2 ·Neurology

    VRNT

    FDA 510(k)
    FDA Class 2 ·Neurology

    Smileyscope System (Therapy Mode)

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all