← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 890.5800
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
PM
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K254004Cognifisense, Inc. · 510k2026-04-10
K251519Appliedvr · 510k2025-08-13
K243417Appliedvr · 510k2024-12-04

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →