# K251519: RelieVRx (Pico G3)

- Pathway: 510(k) (Traditional)
- Applicant: Appliedvr
- Decided: Aug 13, 2025 after 89 days
- Product code: QRA (Virtual Reality Behavioral Therapy Device For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 890.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN210014 (2021). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243417: RelieVRx, Appliedvr (2024) Summary page 5.

## Indications for use
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 and pain interference associated with chronic lower back pain.

Source page: https://510kreport.com/device/K251519
Methodology: https://510kreport.com/methodology