De Novo · Granted
GrantedEaseVRx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Appliedvr, Inc. · QRA Virtual Reality Behavioral Therapy Device For Pain Relief
Granted on Nov 16, 2021 as a new device type through De Novo after a 231-day review. 5 later devices descend from it.
- Decided
- Nov 16, 2021
- Review
- 231 days
- Class
- Class II
- Product code
- QRA
- Recalls
- None
5 later devices descend from it, 3 citing it directly.
- This deviceDEN210014 EaseVRxAppliedvr, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK243417 RelieVRxAppliedvr · 2024
- Descendant · cites it directly · 1 of its ownK230814 VRNTCognifisense, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK254004 VRNTCognifisense, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK251519 RelieVRx (Pico G3)Appliedvr · 2025
- Descendant · cites it directly · 0 of its ownK230825 Smileyscope System (Therapy Mode)Smileyscope Holding, Inc. · 2023
Most influential descendants
Showing 5 of 5 · See all- K243417RelieVRxAppliedvr · 2024 · cites it directly1descendant
- K230814VRNTCognifisense, Inc. · 2023 · cites it directly1descendant
- K254004VRNTCognifisense, Inc. · 2026 · 2 generations on0descendants
- K251519RelieVRx (Pico G3)Appliedvr · 2025 · 2 generations on0descendants
- K230825Smileyscope System (Therapy Mode)Smileyscope Holding, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN210014 | EaseVRx | Appliedvr, Inc. | 2021 | — |
| +1 | K243417 | RelieVRx | Appliedvr | 2024 | — |
| +1 | K230814 | VRNT | Cognifisense, Inc. | 2023 | — |
| +2 | K254004 | VRNT | Cognifisense, Inc. | 2026 | — |
| +2 | K251519 | RelieVRx (Pico G3) | Appliedvr | 2025 | — |
| +1 | K230825 | Smileyscope System (Therapy Mode) | Smileyscope Holding, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QRA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QRA device
- #1 K243417 RelieVRxscore 11.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K243417 (Appliedvr, 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QRA devicesQRA Virtual Reality Behavioral Therapy Device For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QRA
Too few QRA 510(k)s in any year since 2007 to give a median.
Recalls per year · QRA
No recall names QRA since 2007.
Adverse event reports per year · QRA
No MAUDE report names QRA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
EaseVRx is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on cognitive behavioral therapy skills and other evidence-based behavioral methods for patients (age 18 and older) with a diagnosis of chronic lower back-pain (defined as moderate to severe pain lasting longer than three months). The device is intended for in-home use for the reduction of pain and pain interference associated with chronic lower back pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN210014 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN210014: EaseVRx.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN210014
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026