# DEN210014: EaseVRx

- Pathway: De Novo (Direct)
- Applicant: Appliedvr, Inc.
- Decided: Nov 16, 2021 after 231 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K243417: RelieVRx (2024), 1 descendant of its own
- K230814: VRNT (2023), 1 descendant of its own
- K254004: VRNT (2026), 0 descendants of its own
- K251519: RelieVRx (Pico G3) (2025), 0 descendants of its own
- K230825: Smileyscope System (Therapy Mode) (2023), 0 descendants of its own

## Indications for use
EaseVRx 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/DEN210014
Methodology: https://510kreport.com/methodology