Virtual Reality Behavioral Therapy Device For Pain Relief

QRA · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 890.5800

Classification

FDA Product Code: QRA
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 890.5800
Review panel: PM
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 6
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown