QRAClass II
Virtual Reality Behavioral Therapy Device For Pain Relief
Neurology · 21 CFR 890.5800
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.
MDR events0All time
Recalls1All time
Registered firms3Currently listed
510(k) clearances6All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
1 recall events for this product code
Registered firms
3 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Cognifisense, Inc.Apr 10, 2026
K254004 · VRNT
- AppliedvrAug 13, 2025
K251519 · RelieVRx (Pico G3)
- AppliedvrDec 4, 2024
K243417 · RelieVRx
- Cognifisense, Inc.Oct 31, 2023
K230814 · VRNT
- Smileyscope Holding, Inc.Sep 25, 2023
K230825 · Smileyscope System (Therapy Mode)
- Appliedvr, Inc.Nov 16, 2021
DEN210014 · EaseVRx