QRA

Virtual Reality Behavioral Therapy Device For Pain Relief

Product code
QRA
Device name
Virtual Reality Behavioral Therapy Device For Pain Relief
Device class
Class 2
21 CFR
21 CFR 890.5800
Medical specialty
Neurology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
6

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2026-04-10.

NumberDecision dateApplicantDevice nameSummary
K2540042026-04-10Cognifisense, Inc.VRNTPDF
K2515192025-08-13AppliedvrRelieVRx (Pico G3)PDF
K2434172024-12-04AppliedvrRelieVRxPDF
K2308142023-10-31Cognifisense, Inc.VRNTPDF
K2308252023-09-25Smileyscope Holding, Inc.Smileyscope System (Therapy Mode)PDF

5 summaries are archived here for direct download.

Official FDA classification page: QRA
Classification and pathway per current FDA publications. Data from openFDA (CC0).