510(k) · Cleared
ClearedRelieVRx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Appliedvr · QRA Virtual Reality Behavioral Therapy Device For Pain Relief
Cleared on Dec 4, 2024 as substantially equivalent to DEN210014 (Appliedvr, Inc., 2021) after a 30-day review. Its family tree reaches back 1 generation to 2021. 1 later device descends from it.
- Decided
- Dec 4, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- QRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN210014 (2021). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K251519RelieVRx (Pico G3)Appliedvr · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN210014 | EaseVRx | Appliedvr, Inc. | 2021 | — |
| 0 (this device) | K243417 | RelieVRx | Appliedvr | 2024 | — |
| +1 | K251519 | RelieVRx (Pico G3) | Appliedvr | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA 510(k) 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 K254004 VRNTscore 11.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN210014 | EaseVRxSummary page 5…tual reality behavioral therapy device for pain relief Class: II Product Code: QRA Predicate Device: EaseVRx (DEN210014) Indications for Use RelieVRx is a prescription-use immersive virtual reality system intended to provide adjunctive treatment ba… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251519 | RelieVRx (Pico G3) | 2025 | 0 |
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?
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. 2024, 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?
RelieVRx 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/K243417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243417: RelieVRx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243417
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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