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510(k) Data Aggregation
K Number
DEN210014Device Name
EaseVRx
Manufacturer
AppliedVR, Inc.
Date Cleared
2021-11-16
(231 days)
Product Code
QRA, ORA
Regulation Number
890.5800Why 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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