510(k) · Cleared
ClearedTRZ-CG Power Positioning System with Center-of-Gravity Shifting Power Tilt, Recline, and Power Elevating Seat
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 30, 2002 as substantially equivalent to K991658 (Permobil AB, 1999) after a 99-day review. Its family tree reaches back 2 generations to 1997. 8 later devices descend from it.
- Decided
- Jul 30, 2002
- Review
- 99 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K960951 (1997). 3 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK960951 Permobil Chairman L/CS 8Permobil AB · 1997
- 1 generation backK991658 Permobil Powered Wheelchair 1280Permobil AB · 1999 · Recalled
- This deviceK021264 TRZ-CG Power Positioning System with Center-of-Gravity Shifting…Motion Concepts · 2002
- Descendant · cites it directly · 5 of its ownK150574 Modular Power Positioning SystemMotion Concepts · 2015
- Descendant · 2 generations on · 3 of its ownK170507 Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX…Invacare Corporation · 2017 · Recalled
- Descendant · 3 generations on · 1 of its ownK192216 Invacare AVIVA FX Power Wheelchair, Model: IFX-20MPInvacare Corporation · 2020 · Recalled
- Descendant · 4 generations on · 0 of its ownK202379 Invacare AVIVA Storm RX Power ChairInvacare Corporation · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK182995 Bariatric Power Positioning System (BPPS)Motion Concepts · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K150574Modular Power Positioning SystemMotion Concepts · 2015 · cites it directly5descendants
- K170507Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX…Invacare Corporation · 2017 · 2 generations on3descendants
- K192216Invacare AVIVA FX Power Wheelchair, Model: IFX-20MPInvacare Corporation · 2020 · 3 generations on1descendant
- K202379Invacare AVIVA Storm RX Power ChairInvacare Corporation · 2021 · 4 generations on0descendants
- K182995Bariatric Power Positioning System (BPPS)Motion Concepts · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960951 | Permobil Chairman L/CS 8 | Permobil AB | 1997 | — |
| −1 | K991658 | Permobil Powered Wheelchair 1280 | Permobil AB | 1999 | 5 |
| 0 (this device) | K021264 | TRZ-CG Power Positioning System with Center-of-Gravity Shifting Power Tilt… | Motion Concepts | 2002 | — |
| +1 | K150574 | Modular Power Positioning System | Motion Concepts | 2015 | — |
| +2 | K170507 | Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics… | Invacare Corporation | 2017 | 2 |
| +3 | K192216 | Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP | Invacare Corporation | 2020 | 1 |
| +4 | K202379 | Invacare AVIVA Storm RX Power Chair | Invacare Corporation | 2021 | 1 |
| +2 | K182995 | Bariatric Power Positioning System (BPPS) | Motion Concepts | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 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 |
|---|---|---|---|
| * | K991658 | Permobil Powered Wheelchair 1280Summary page 1…Positioning System Classification Name: Powered Wheelchair Identification of Predicate Device: Permobil Powered Wheelchair 1280 (K991658) Description of Device: . The TRX-CG Power Positioning System consists of a power tilt unit with optional… | 1999 |
What descends from it? (8)
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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K150574 (Motion Concepts, 2015) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K991658.
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: +:+ All positioning benefits associated with the tilflrecline product - P Comfort - As with any individual - able-bodied or disabled - changes in position are necessary to maintain a state of comfort. > Repositioning - Individuals…
Read the full statement (220 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:
+:+ All positioning benefits associated with the tilflrecline product -
P 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 and/or reclining. By changing the individual’s orientation in space, pressures caused by gravity will shift.
+:+ PositioningNersatility - Individuals are able to reach higher elevations in a seated position, increasing their range of motion and accessibility.
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-CG Power Positioning Systems are to be installed ONLY by qualified Dealers.
The above indications for use are identical to those of the Permobil Tilt/Recline/Elevating Se.aS Systemto which we -areclaiming -substantial equivalence.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021264 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021264: TRZ-CG Power Positioning System with Center-of-Gravity Shifting Power Tilt, Recline, and Power Elevating Seat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021264
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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