FDA Product Code QRA: Virtual Reality Behavioral Therapy Device For Pain Relief
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.
Leading manufacturers include Appliedvr, Cognifisense, Inc. and Smileyscope Holding, Inc..
FDA 510(k) Cleared Virtual Reality Behavioral Therapy Device For Pain Relief Devices (Product Code QRA)
About Product Code QRA - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code QRA since 2021, with 5 receiving FDA clearance (average review time: 145 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QRA have taken an average of 78 days to reach a decision - down from 212 days historically, suggesting improved FDA processing for this classification.
QRA devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →