DeviceClearance

Product code QRA— Neurology

VRNT

Classification name
Virtual Reality Behavioral Therapy Device For Pain Relief
Device class
Class 2
Regulation
21 CFR 890.5800
Advisory panel
Neurology
Total cleared
6
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QRA under 21 CFR 890.5800, via openFDA

Market context for product code QRA

FDA has cleared 6 devices under product code QRA between 2021 and 2026, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QRA

Recent clearances under product code QRA

Data sourced from openFDA. This site is unofficial and independent of the FDA.