510(k) · Cleared
ClearedTRS-2000 Power Tilt/Power Recline System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accelerated Rehab Designs, Inc. · ITI Wheelchair, Powered
Cleared on Aug 1, 2001 as substantially equivalent to K981837 (Motion Concepts, 1998) and 1 other predicate after a 12-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Aug 1, 2001
- Review
- 12 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K981837 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK981837 TRX-CG Center-of-Gravity Shifting Power Tilt and Recline SystemsMotion Concepts · 1998
- This deviceK012281 TRS-2000 Power Tilt/Power Recline SystemAccelerated Rehab Designs, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981837 | TRX-CG Center-of-Gravity Shifting Power Tilt and Recline Systems | Motion Concepts | 1998 | — |
| 0 (this device) | K012281 | TRS-2000 Power Tilt/Power Recline System | Accelerated Rehab Designs, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981837 | TRX-CG Center-of-Gravity Shifting Power Tilt and Recline SystemsSummary page 1…/ Wheelchair, Powered PRODUCT CODE: ITI REGULATION No: 890.3860 TYPE: Traditional SUBSTANCIAL EQUIVALENCE: Motion Concepts: TRx-CG Center of Gravity Shifting Power Tilt K981837 ) Medical Industries of America Optima 2000 Ko11053 Invacare Corporation. Tilt/Recliner for Power Wheelchairs, Model 2G Kgg1119… | 1998 |
| * | K011053 | Optima | 2001 |
| Kept off the family tree | K991119 | FDA’s K991119 is Tilt/Recliner for Power Wheelchairs, Model 2G Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K981837.
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 "TRS-2000 Power Tilt / Power Recline Seating System” is an aftermarket Power Seating System utilizing the various wheelchair manufacturers base frames and Accelerated Rehab Designs Seat Frame Assembly. The TR-2000 Power Tilt / Power Recline Seating System replaces the existing wheelchair manufacturers seat frame and attaches to the wheelchair base frame allowing for the Tilting and Reclining action of the system upon activation of the Low-Amp Toggle…
Read the full statement (244 words)
The "TRS-2000 Power Tilt / Power Recline Seating System” is an aftermarket Power Seating System utilizing the various wheelchair manufacturers base frames and Accelerated Rehab Designs Seat Frame Assembly. The TR-2000 Power Tilt / Power Recline Seating System replaces the existing wheelchair manufacturers seat frame and attaches to the wheelchair base frame allowing for the Tilting and Reclining action of the system upon activation of the Low-Amp Toggle Switch or any alternative low-amp switch that the client may choose to operate. The TRS-2000 System is modular in design and may be added to an existing Power Tilt System, or be a stand alone power recline system.
The TRS-2000 System has no software based electronic components.
The TRS-2000 System is appropriate for individuals who require chances in position without the help of an attendant. Power recline systems are utilized by individuals with a variety of physical disabilities. Some of the indications for use include:
The reduction of sitting pressure, may prevent Decubitus Ulcers
Gravity Assisted Positioning
Increased Sitting Stability
Assistance in feeding, Improved Swallowing
Increased Respiratory Function
Decrease Muscle Tone
Comfort Adjustments
Accelerated Rehab Designs makes no claims as to the therapeutic effectiveness of the product(s) listed. Accelerated Rehab Designs recommends that an accredited Rehabilitation Therapist and Supplier evaluate all customers of its products.
The above indications for use are identical to those of the Motion Concepts, Invacare Corporation, and Medical Industries of America Power Tilt / Recline Seating Systems we are claiming substantial equivalence.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012281: TRS-2000 Power Tilt/Power Recline System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012281
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026