Virtual Reality Behavioral Therapy Device For Pain Relief
QRA is the FDA product code for Virtual Reality Behavioral Therapy Device For Pain Relief, a class II device type, regulated under 21 CFR 890.5800. FDA's definition for this code reads: "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". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- QRA
- Device name
- Virtual Reality Behavioral Therapy Device For Pain Relief
- FDA 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.
- Regulation
- 21 CFR 890.5800
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 6
- Ingested recalls
- 1
Clearances, product code QRA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code QRA| Applicant | Clearances |
|---|---|
| Appliedvr | 3 |
| CognifiSense, Inc. | 2 |
| Smileyscope Holding, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
