QRA
6 FDA 510(k) clearances · Product code
185 daysmedian time to decision
231 days90th percentile
6clearances measured
FDA profile
- Official device name
- Virtual Reality Behavioral Therapy Device For Pain Relief
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5800
- Medical specialty
- Neurology
- 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.
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| Record | Firm | Date |
|---|---|---|
| VRNT (K254004) | Cognifisense, Inc. | 2026-04-10 |
| RelieVRx (Pico G3) (K251519) | Appliedvr | 2025-08-13 |
| RelieVRx (K243417) | Appliedvr | 2024-12-04 |
| VRNT (K230814) | Cognifisense, Inc. | 2023-10-31 |
| Smileyscope System (Therapy Mode) (K230825) | Smileyscope Holding, Inc. | 2023-09-25 |
| EaseVRx (DEN210014) | Appliedvr, Inc. | 2021-11-16 |
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Every clearance here is in the API, with alerts when new ones post.