QRA — Virtual Reality Behavioral Therapy Device For Pain Relief Class II
Classification Details
- Product Code
- QRA
- Device Class
- Class II
- Regulation Number
- 890.5800
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251519 | appliedvr | RelieVRx (Pico G3) | August 13, 2025 |
| K243417 | appliedvr | RelieVRx | December 4, 2024 |
| K230814 | cognifisense | VRNT | October 31, 2023 |
| K230825 | smileyscope holding | Smileyscope System (Therapy Mode) | September 25, 2023 |
| DEN210014 | appliedvr | EaseVRx | November 16, 2021 |