FDA product code QRA: Virtual Reality Behavioral Therapy Device For Pain Relief
QRA is the FDA product code for virtual reality behavioral therapy device for pain relief. It is a Class II device, regulated under 21 CFR 890.5800 and reviewed by the Physical Medicine panel. FDA has cleared 5 510(k) submissions under QRA, 5 in the last five years, from 3 different applicants. The average 510(k) review took 128 days (median 116); 78 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for QRA devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Virtual Reality Behavioral Therapy Device For Pain Relief |
| Device class | Class II |
| Regulation | 21 CFR 890.5800 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for QRA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 2 | 203 |
| 2024 | 1 | 30 |
| 2025 | 1 | 89 |
| 2026 | 1 | 116 |
Compare with all 510(k) review times · Search every QRA clearance
Top QRA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cognifisense, Inc. | 2 | 2026-04-10 |
| Appliedvr | 2 | 2025-08-13 |
| Smileyscope Holding, Inc. | 1 | 2023-09-25 |
Most recent QRA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254004 | Cognifisense, Inc. | VRNT | 2026-04-10 | 116 |
| K251519 | Appliedvr | RelieVRx (Pico G3) | 2025-08-13 | 89 |
| K243417 | Appliedvr | RelieVRx | 2024-12-04 | 30 |
| K230814 | Cognifisense, Inc. | VRNT | 2023-10-31 | 221 |
| K230825 | Smileyscope Holding, Inc. | Smileyscope System (Therapy Mode) | 2023-09-25 | 185 |
Recalls for QRA devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2023-02-27.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code QRA?
QRA is the FDA product code for virtual reality behavioral therapy device for pain relief. It is a Class II device, regulated under 21 CFR 890.5800 and reviewed by the Physical Medicine panel.
What device class is QRA?
Class II, regulation 21 CFR 890.5800. Typical premarket route: 510(k).
How long does a 510(k) take for product code QRA?
Across 5 cleared submissions the average was 128 days from receipt to decision (median 116).
Which companies have the most QRA clearances?
Cognifisense, Inc. (2); Appliedvr (2); Smileyscope Holding, Inc. (1).
Have QRA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-02-27.
Next steps
- Run an FDA pathway report with predicate devices for product code QRA
- Run a recall and safety report across every QRA manufacturer
- Watch product code QRA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Physical Medicine product codes · FDA product code lookup · 510(k) database search · 510(k) review times