Virtual Reality Behavioral Therapy Device For Pain Relief
The Virtual Reality Behavioral Therapy Device for Pain Relief is a software-driven device intended to provide behavioral therapy for patients experiencing pain, administered via a virtual reality display. The therapy content is delivered through a software program using a VR headset interface. Classified as FDA Class 2 under regulation 890.5800, it requires 510(k) clearance and is reviewed under the Neurology specialty with the Physical Medicine review panel. The device is non-implantable and not life-sustaining.
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Basic Information
- Product Code
- QRA
- Device Class
- FDA class 2
- Regulation Number
- 890.5800
- Medical Specialty
- Neurology
- Review Panel
- PM
- Submission Type
- 1
Device Characteristics
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) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K254004 | VRNT | Apr 10, 2026 | Substantially Equivalent | Cognifisense, Inc. |
| K251519 | RelieVRx (Pico G3) | Aug 13, 2025 | Substantially Equivalent | Appliedvr |
| K243417 | RelieVRx | Dec 04, 2024 | Substantially Equivalent | Appliedvr |
| K230814 | VRNT | Oct 31, 2023 | Substantially Equivalent | Cognifisense, Inc. |
| K230825 | Smileyscope System (Therapy Mode) | Sep 25, 2023 | Substantially Equivalent | Smileyscope Holding, Inc. |
| DEN210014 | EaseVRx | Nov 16, 2021 | Unknown | Appliedvr, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.