510(k) · Cleared
Recalled · Class II · 2014TRX Vertical Positioner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Motion Concepts · ITI Wheelchair, Powered
Cleared on Nov 21, 2002 as substantially equivalent to K963817 (Levo USA, 1997) after a 41-day review. Its family tree reaches back 1 generation to 1997. It has been recalled once.
- Decided
- Nov 21, 2002
- Review
- 41 days
- Class
- Class II
- Product code
- ITI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963817 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK963817 Levo Mobil LCMLevo USA · 1997
- This deviceK023426 TRX Vertical PositionerMotion Concepts · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963817 | Levo Mobil LCM | Levo USA | 1997 | — |
| 0 (this device) | K023426 | TRX Vertical Positioner | Motion Concepts | 2002 | — |
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 ITI? 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 ITI device
- #1 K220747 Power Wheelchair (N5515B)score 40.2 · 4 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 |
|---|---|---|---|
| * | K963817 | Levo Mobil LCMSummary page 1…Power Positioning System Classification Name: Powered Wheelchair Identification of Predicate Device: Levo Mobile LCM (K963817) 9 Description of Device: The TRX Vertical Positioner is used to add the vertical positioning function to the… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2014 | Class II | Z-2657-2014 | Device Design | Motion Concepts identified that there is a possibility of knee support failure occurring through fatigue of two attachment bolts in the Vertical Position System (TRx Vertical Positioner). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K963817.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITI
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITI
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITI
13so far in 2026, the most since 2007
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · ITI
647in 2025
MAUDE reports naming product code ITI, 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 | 18 | 42 | 3 | 123 |
| 2008 | 9 | 49 | 3 | 133 |
| 2009 | 7 | 63 | 1 | 183 |
| 2010 | 6 | 46 | 2 | 157 |
| 2011 | 4 | 101 | 0 | 525 |
| 2012 | 6 | 155 | 1 | 2,919 |
| 2013 | 5 | 177 | 0 | 8,741 |
| 2014 | 5 | 213 | 0 | 7,282 |
| 2015 | 10 | 174 | 0 | 4,685 |
| 2016 | 6 | 173 | 1 | 1,575 |
| 2017 | 4 | 159 | 2 | 301 |
| 2018 | 4 | 117 | 0 | 273 |
| 2019 | 3 | 244 | 0 | 264 |
| 2020 | 6 | 278 | 0 | 205 |
| 2021 | 13 | 209 | 3 | 166 |
| 2022 | 16 | 96 | 0 | 135 |
| 2023 | 8 | 128 | 0 | 223 |
| 2024 | 38 | 125 | 1 | 146 |
| 2025 | 29 | 90 | 3 (2) | 647 |
| 2026 | 36 | 108 | 13 | — |
What is it indicated for?
The TRX Vertical Positioner is appropriate for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include: All positioning benefits associated with the tilt/recline product - Comfort - As with any individual - able-bodied or disabled - changes in position are necessary to maintain a state of comfort. Repositioning -…
Read the full statement (228 words)
The TRX Vertical Positioner is appropriate for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include:
All positioning benefits associated with the tilt/recline product -
Comfort - As with any individual - able-bodied or disabled - changes in position are necessary to maintain a state of comfort.
Repositioning - Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position.
Pressure relief - Individuals who wish, from time to time, to redistribute pressures from one area of the body to another, can do so by tilting, reclining or vertical positioning. By changing the individual’s orientation in space, pressures caused by gravity will shift.
Positioning Versatility - Individuals are able to reach higher elevations, increasing their range of motion and accessibility.
The TRX Vertical Positioner is used to add the vertical positioning function to the tilt, recline, and elevating functions already available in with the TRX Power Positioning System defined in K021264.
Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed. TRX Vertical Positioners are to be installed ONLY by qualified Dealers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023426: TRX Vertical Positioner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023426
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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