RelieVRx (Pico G3)

RelieVRx is a prescription virtual reality system that delivers cognitive behavioral therapy and other evidence-based behavioral methods to patients age 18 and older with chronic lower back pain (moderate to severe, lasting longer than 3 months). The device is used at home in a seated position to reduce pain and pain interference through an 8-week, 56-day program with sessions averaging 6 minutes each.

The subject device uses an identical head-mounted display (GoerTek/Pico G3 with Qualcomm XR2 processor) with identical specifications including 3664 x 1920 screen resolution, 90 fps frame rate, 3 degrees of freedom tracking, and rechargeable lithium battery power. All technical specifications including screen resolution, field of view, CPU, weight, storage, and wireless specifications are unchanged from the predicate device K243417.

IEC 60601-1/11 (electrical and mechanical safety), IEC 60601-1-2 (electromagnetic compatibility), and unspecified environmental and acoustic safety standards are cited for testing changes under the Predetermined Change Control Plan. No new nonclinical performance testing was conducted for this submission.

Substantial equivalence is established because the subject and predicate devices share identical intended use, indications for use, technological characteristics, hardware platform (same headset model and specifications), principles of operation based on CBT and behavioral therapy, and regulatory classification. The only change is the addition of a Predetermined Change Control Plan for future hardware updates, which does not alter the device's current safety or effectiveness profile and maintains the same user experience and therapeutic delivery mechanism.