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510(k) Data Aggregation

    K Number
    DEN210014
    Device Name
    EaseVRx
    Manufacturer
    AppliedVR, Inc.
    Date Cleared
    2021-11-16

    (231 days)

    Product Code
    QRA, ORA
    Regulation Number
    890.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    AppliedVR, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EaseVRx is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on cognitive behavioral therapy skills and other evidencebased behavioral methods for patients (age 18 and older) with a diagnosis of chronic lower back-pain (defined as moderate to severe pain lasting longer than three months). The device is intended for in-home use for the reduction of pain and pain interference associated with chronic lower back pain.
    Device Description
    EaseVRx is an immersive virtual reality (VR) system which delivers 3-D VR treatment that incorporates principles of cognitive behavioral therapy (CBT), other behavioral methods, and mindfulness strategies to treat patients diagnosed with chronic pain. It is a prescription-use device which uses preloaded software content on a proprietary hardware platform to deliver treatment. The EaseVRx device, shown in the figures below, consists of an off-the-shelf VR head-mounted display (Figure 1) with added Breathing Amplifier (Figure 2) and AppliedVR developed software. The Breathing Amplifier is a mechanical attachment added to the commercially available headset which enables diaphragmatic breathing exercises designed to enhance the user's engagement by amplifying the user's exhalation into the on-board microphone. The device is also marketed with an optional hand-held controller to aid in navigating the user interface.
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