BEUDAMED
    FDA Enforcement Class II Completed

    RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.

    Recall: Z-2044-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-2044-2023
    Event ID
    92389
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Appliedvr
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 5, 2023
    Initiation Date
    February 27, 2023
    Classification Date
    June 29, 2023
    Address
    16760 Stagg St Ste 216, N/A, Van Nuys, CA, 91406-1642, United States

    Description

    RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.

    Reason

    There is the potential for the program software to malfunction which will not allow it to move forward to the next session.

    Code Info

    Serial Number: PA7940RGG5130514B; UDI: 0100850038247027211001077

    Distribution

    US: NY OUS: None

    Quantity

    1 unit