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Short answer: In US regulation, “VR pain therapy” is a defined medical device type. FDA classifies a “virtual reality behavioral therapy device for pain relief” under product code QRA and 21 CFR 890.5800 as Class II, meaning special controls apply. What the regulation describes is behavioral therapy delivered through a virtual reality display by software containing the therapy content. A headset by itself is not the regulated device. Facts below were checked against openFDA and the Code of Federal Regulations on 2026-10-31.
General product and regulatory information only. This page is not medical advice and does not recommend any treatment or device.
Definition and scope: how FDA defines it
21 CFR 890.5800(a) states that 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 that utilizes a software program containing the behavioral therapy content.” openFDA’s classification record for product code QRA carries the same definition and lists the device as Class II, review panel PM, with Neurology as the medical specialty.
Two parts of that wording carry the weight. The intended use is behavioral therapy for patients with pain, and the delivery route is a VR display running a software program that contains the therapy content. For a lab, clinic or procurement team, this means the product being evaluated is the combination of display, software and therapy content, as labeled by its manufacturer.
How it is used in practice
The regulation describes the therapy as administered through the VR display using the software’s behavioral therapy content. The regulation does not set a session schedule, a patient population or a treatment protocol; those come from each manufacturer’s labeling and instructions for use, which are the documents to read for any specific product. Use of any such device for a patient is a clinician’s decision.
Devices listed under product code QRA
The openFDA 510(k) database lists these entries under QRA (checked 2026-10-31). The first was granted through the De Novo pathway, and later devices were cleared through 510(k).
| Device name | Sponsor | FDA number | Decision date | Pathway shown by openFDA |
|---|---|---|---|---|
| EaseVRx | AppliedVR, Inc. | DEN210014 | 2021-11-16 | De Novo |
| Smileyscope System (Therapy Mode) | Smileyscope Holding, Inc. | K230825 | 2023-09-25 | Traditional 510(k) |
| VRNT | Cognifisense, Inc. | K230814 | 2023-10-31 | Traditional 510(k) |
| RelieVRx | AppliedVR | K243417 | 2024-12-04 | Special 510(k) |
| RelieVRx (Pico G3) | AppliedVR | K251519 | 2025-08-13 | Traditional 510(k) |
| VRNT | Cognifisense, Inc. | K254004 | 2026-04-10 | Special 510(k) |
The pattern is the standard one for a new device type: a De Novo request creates the classification and its special controls, and later devices of the same type can then be cleared by 510(k) against it. See FDA De Novo classification and predicate devices and substantial equivalence. Inclusion in this list reflects FDA’s database records, not a ranking or endorsement.
What the special controls require
21 CFR 890.5800(b) lists five special controls. Read as a documentation checklist for someone reviewing a product’s regulatory file, a device in this class should come with evidence of the following:
- Clinical performance testing under the labeled conditions for use, validating the model of behavioral therapy as implemented by the device and evaluating all adverse events.
- Biocompatibility of the patient-contacting components. See FDA guidance on biocompatibility.
- Software verification, validation and hazard analysis. Related background: software as a medical device.
- Electromagnetic compatibility and electrical, mechanical and thermal safety testing.
- Labeling that includes a warning about the risk of nausea and motion sickness, a warning about the risk of discomfort from the device, and a summary of the clinical testing with the device.
The Federal Register final order that created the classification (88 FR 985, 6 January 2023) pairs identified risks with these mitigations; for example, adverse tissue reaction is addressed by biocompatibility and nausea and motion sickness by labeling and testing.
Common misunderstandings
Is any VR headset a pain-therapy device?
No. The regulatory definition covers a device intended to provide behavioral therapy for patients with pain, delivered by software containing that therapy content. A general-purpose headset or entertainment content is not described by 21 CFR 890.5800. Whether a given product is a regulated medical device depends on its intended use; see what is a medical device.
Does Class II mean the device works better than others?
No. Class II is a risk-based regulatory class meaning special controls apply, in addition to general controls. It is not an efficacy ranking, and the classification says nothing about which product suits a particular patient. For how pathways differ, see FDA clearance vs. approval.
Does FDA clearance mean the same as FDA approval?
No. The devices above were granted through De Novo or 510(k) pathways, which are not premarket approval (PMA). The terms are not interchangeable.
FAQ
What is VR pain therapy?
In FDA’s definition, it is behavioral therapy for patients with pain, administered through a virtual reality display using software that contains the therapy content (21 CFR 890.5800(a)).
How is VR pain therapy classified by FDA?
Class II with special controls, under product code QRA and regulation number 890.5800, per openFDA’s classification record.
Which VR pain therapy devices are listed with FDA?
openFDA lists six entries under QRA as of 2026-10-31: EaseVRx, Smileyscope System (Therapy Mode), two VRNT submissions, and two RelieVRx submissions (table above).
What warnings must the labeling carry?
The special controls require labeling to include a warning about nausea and motion sickness, a warning about discomfort from the device, and a summary of clinical testing with the device.
Sources
- openFDA device classification, product code QRA: https://api.fda.gov/device/classification.json?search=product_code:QRA (checked 2026-10-31).
- openFDA 510(k) database, product code QRA: https://api.fda.gov/device/510k.json?search=product_code:QRA (checked 2026-10-31).
- 21 CFR 890.5800, Virtual reality behavioral therapy device for pain relief: https://www.law.cornell.edu/cfr/text/21/890.5800 (checked 2026-10-31).
- Federal Register, final order of 6 January 2023 (88 FR 985): https://www.govinfo.gov/content/pkg/FR-2023-01-06/pdf/2023-00014.pdf (checked 2026-10-31).
