510(k) · Cleared
ClearedMindMotionPRO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mindmaze SA · LXJ Interactive Rehabilitation Exercise Devices
Cleared on Apr 24, 2017 after a 206-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Apr 24, 2017
- Review
- 206 days
- Class
- Class II
- Product code
- LXJ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK162748 MindMotionPROMindmaze SA · 2017
- Descendant · cites it directly · 0 of its ownK183296 REAL Immersive SystemPenumbra, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K183296REAL Immersive SystemPenumbra, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K162748 | MindMotionPRO | Mindmaze SA | 2017 | — |
| +1 | K183296 | REAL Immersive System | Penumbra, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LXJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K183296 | REAL Immersive System | 2019 | 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?
- Of its descendants, K183296 (Penumbra, Inc., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LXJ devicesLXJ Interactive Rehabilitation Exercise Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LXJ
3in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LXJ
224in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LXJ
No recall names LXJ since 2007.
Adverse event reports per year · LXJ
1in 2018
MAUDE reports naming product code LXJ, not matched to any one device; reports are not rates.
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 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 182 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 231 | 0 | 1 |
| 2019 | 3 | 224 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
MindMotionPRO is a 3D imaging and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult patients using a combination of 3D virtual environments and avatars for visual feedback. These rehabilitation exercises are intended to be conducted in a clinical environment and supervised by a medical professional trained in the proper utilization of the MindMotionPRO.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K162748 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162748: MindMotionPRO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162748
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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