QRA
- Product code
- QRA
- Device name
- Virtual Reality Behavioral Therapy Device For Pain Relief
- Device class
- Class 2
- 21 CFR
- 21 CFR 890.5800
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 6
FDA classification definition
A virtual reality behavioral therapy device for pain relief is a device intended to provide behavioral therapy for patients with pain. Therapy is administered via a virtual reality display which utilizes a software program containing the behavioral therapy content.
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254004 | 2026-04-10 | Cognifisense, Inc. | VRNT | |
| K251519 | 2025-08-13 | Appliedvr | RelieVRx (Pico G3) | |
| K243417 | 2024-12-04 | Appliedvr | RelieVRx | |
| K230814 | 2023-10-31 | Cognifisense, Inc. | VRNT | |
| K230825 | 2023-09-25 | Smileyscope Holding, Inc. | Smileyscope System (Therapy Mode) |
Official FDA classification page: QRA
Classification and pathway per current FDA publications. Data from openFDA (CC0).