Search Results

RelieVRx is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on cognitive behavioral therapy skills and other evidence based 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 interference associated with chronic lower back pain.

RelieVRx is an immersive virtual reality (VR) system with preloaded software content on a proprietary hardware platform that delivers automated cognitive behavioral therapy (CBT) and other behavioral methods to patients diagnosed with chronic lower back-pain (defined as moderate to severe pain lasting longer than three months). The VR content is delivered while incorporating CBT to enable diaphragmatic breathing exercises and mindfulness strategies, and is intended to be self-administered, unsupervised in the patient's home while the patient is in a seated position. Each device is intended for single patient use during treatment and can be used on multiple patients over the device lifetime. The medical device does not include nonmedical software and is only effective when treating chronic lower back pain. Similar to the predicate device, EaseVRx (DEN210014), the Relie VRx device consists of an off-the-shelf VR head-mounted display with added Breathing Amplifier 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. No change is being made to the core RelieVRx program used in the pivotal clinical trial conducted for market authorization; the 8-week theme-based structure, weekly VRexperience structure, and daily session structure is unchanged. Minor changes were made to the content of the 56 VR sessions. Briefly, 46 of 56 VR sessions are unchanged. Of the 10 sessions that have been updated, there were 3 changes to Relaxation/Interoceptive sessions, and 7 changes to Distraction sessions. The 3 Relaxation/Interoceptive sessions include slightly altered minor graphical rendering to improve images. The 7 changes to Distraction sessions include changed background which is dimmer to help to user to achieve the goal of attentional focus (dragonfly). There is no negative impact on safety or effectiveness.

VRNT is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on cognitive behavioral therapy skills and other evidence-based 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.

VRNT is an immersive virtual reality (VR) system which delivers behavioral therapy content for the treatment of chronic pain via virtual reality hardware. VRNT is a prescription-use device containing pre-loaded, proprietary content on commercially available VR hardware shown in the figure below. The behavioral content incorporates cognitive behavioral therapy (CBT) skills and other evidence-based behavioral methods. VRNT uses a virtual reality system called GearVR, consisting of a virtual reality head-mounted display, a hand controller and a smartphone VRNT is designed to be used in an 8-week treatment program which delivers a multifaceted combination of pain management skills training through a sequence of daily sessions (5 days a week) ranging from 7-27 minutes in length (average of 20 minutes). Similar to multisession behavioral treatment program begins with basic skills and progresses to more advanced skills over the 8 weeks. Initial themes in VRNT are focused on understanding the basic science behind chronic pain and developing rudimentary breathing, bodily awareness and mindfulness, relaxation and interoception skills. Later themes build on these skills; they expand on interoception, add passive distraction and refocusing attention, thought appraisal skills for managing emotion triggers. Finally, the program provides opportunities to practice applying the education and self-regulation skills when faced with actual pain triggers. The treatment content, thus, allows the patient over time to build upon education, skills training and their own experiential learning in a manner that increasingly mimics real-world situations.

The Smileyscope System's Therapy Mode is a prescription-use intual reality system intended to provide adjunctive treatment based on guided relaxation and other evidence-based behavioral methods for patients aged 4-1 years who can cooperate and interact with the device at a developmentally appropriate level. The Smileyscope Therapy Mode is intended to temporarily reduce and/or manage pain and temporarily relieve acute procedural with needle procedures (e.g., venipuncture, IV placement, vaccination, port access, subcutaneous injections). The device is not intended to treat anxiety disorders or specific phobias (e.g. trypanophobia).

Smileyscope is an immersive virtual reality (VR) device, consisting of Hardware and Software components. In Smileyscope Therapy mode, the device delivers 3-dimensional virtual reality treatment based on guided relaxation and other evidence-based behavioral methods to temporarily reduce pain and temporarily relieve acute procedural anxiety in individuals undergoing needle procedures. This prescription-use device uses pre-loaded software on a proprietary hardware and software platform to deliver treatment. The Smileyscope device is supplied with a USB charger and USB cable to facilitate charging.

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.

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.