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QRAClass II

Virtual Reality Behavioral Therapy Device For Pain Relief

21 CFR 890.5800 / Neurology

QRA is the FDA product code for Virtual Reality Behavioral Therapy Device For Pain Relief, a class II device type, regulated under 21 CFR 890.5800. FDA's definition for this code reads: "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". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
QRA
Device name
Virtual Reality Behavioral Therapy Device For Pain Relief
FDA 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.
Regulation
21 CFR 890.5800
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
1

Clearances, product code QRA

By decision year
6 clearances under product code QRA with a decision year between 2021 and 2026, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QRA by decision year
YearClearances
20211
20232
20241
20251
20261

Applicants with the most clearances

Product code QRA
Applicants holding the most 510(k) clearances under product code QRA
ApplicantClearances
Appliedvr3
CognifiSense, Inc.2
Smileyscope Holding, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code