510(k) · Cleared
ClearedTRX-CG Center-of-Gravity Shifting Power Tilt and Recline Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Motion Concepts · ITI Wheelchair, Powered
Cleared on Jul 9, 1998 after a 44-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jul 9, 1998
- Review
- 44 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK981837 TRX-CG Center-of-Gravity Shifting Power Tilt and Recline SystemsMotion Concepts · 1998
- Descendant · cites it directly · 1 of its ownK992804 T-2000-Power Tilt Seating System, Models Ard-Tstorm, Ard-TP-320…Accelerated Rehab Designs, Inc. · 2000
- Descendant · 2 generations on · 0 of its ownK050264 Stealth Products Seating SystemStealth Products · 2005
- Descendant · cites it directly · 0 of its ownK033263 K-Tech 2 Power Tilt Seating System, Model K2PTTrack Corporation · 2003
- Descendant · cites it directly · 0 of its ownK012281 TRS-2000 Power Tilt/Power Recline SystemAccelerated Rehab Designs, Inc. · 2001
Most influential descendants
Showing 4 of 4 · See all- K992804T-2000-Power Tilt Seating System, Models Ard-Tstorm, Ard-TP-320, Ard-TG424, Ard-TS525…Accelerated Rehab Designs, Inc. · 2000 · cites it directly1descendant
- K050264Stealth Products Seating SystemStealth Products · 2005 · 2 generations on0descendants
- K033263K-Tech 2 Power Tilt Seating System, Model K2PTTrack Corporation · 2003 · cites it directly0descendants
- K012281TRS-2000 Power Tilt/Power Recline SystemAccelerated Rehab Designs, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981837 | TRX-CG Center-of-Gravity Shifting Power Tilt and Recline Systems | Motion Concepts | 1998 | — |
| +1 | K992804 | T-2000-Power Tilt Seating System, Models Ard-Tstorm, Ard-TP-320, Ard-TG424… | Accelerated Rehab Designs, Inc. | 2000 | — |
| +2 | K050264 | Stealth Products Seating System | Stealth Products | 2005 | — |
| +1 | K033263 | K-Tech 2 Power Tilt Seating System, Model K2PT | Track Corporation | 2003 | — |
| +1 | K012281 | TRS-2000 Power Tilt/Power Recline System | Accelerated Rehab Designs, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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 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 |
|---|---|---|---|
| * | — | Tarsys Tilt and Recline System Named without a submission number |
What descends from it? (4)
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, K992804 (Accelerated Rehab Designs, Inc., 2000) has gone furthest, with 1 descendant of its own.
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-CG 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: 6. Comfort — As with any individual — able-bodied or disabled — changes in position are necessary to maintain a state of comfort. 7. Positioning — Individuals without adequate upper-body stability can be tiited to allow gravity to hold…
Read the full statement (161 words)
The TRx-CG 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:
6. Comfort — As with any individual — able-bodied or disabled — changes in position are
necessary to maintain a state of comfort.
7. Positioning — Individuals without adequate upper-body stability can be tiited to allow
gravity to hold them in position.
8. Pressure Relief or Reduction — Individuals who wish to, from time to time, redistribute
pressures from one area of the body to another, can do so by tilting and/or reclining. By
changing the individual's orientation in space, pressures caused by gravity will shift.
Motion Concepts makes no claims as to the thera{peutic 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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981837: TRX-CG Center-of-Gravity Shifting Power Tilt and Recline Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981837
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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