510(k) · Cleared
ClearedT-2000-Power Tilt Seating System, Models Ard-Tstorm, Ard-TP-320, Ard-TG424, Ard-TS525, Ard-Tjazzy, Ard-Tlancer
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 Feb 3, 2000 as substantially equivalent to K981837 (Motion Concepts, 1998) and 1 other predicate after a 168-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Feb 3, 2000
- Review
- 168 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K972564 (1997). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK972564 Tilt Master CG System (Center of Gravity), Tilt-N-Space-SeatMechanical Application Designs, Inc. · 1997
- This deviceK992804 T-2000-Power Tilt Seating System, Models Ard-Tstorm, Ard-TP-320…Accelerated Rehab Designs, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK050264 Stealth Products Seating SystemStealth Products · 2005
Most influential descendants
Showing 1 of 1 · See all- K050264Stealth Products Seating SystemStealth Products · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972564 | Tilt Master CG System (Center of Gravity), Tilt-N-Space-Seat | Mechanical Application Designs, Inc. | 1997 | — |
| 0 (this device) | K992804 | T-2000-Power Tilt Seating System, Models Ard-Tstorm, Ard-TP-320, Ard-TG424… | Accelerated Rehab Designs, Inc. | 2000 | — |
| +1 | K050264 | Stealth Products Seating System | Stealth Products | 2005 | — |
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 |
|---|---|---|
| 2005 | 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.
| 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 Mechanical Application Designs: ~ Tiltmaster Center of Gravity Power Tilt System K972564 Invacare Corporation. Tarsys Weight Sh… | 1998 |
| * | K972564 | Tilt Master CG System (Center of Gravity), Tilt-N-Space-SeatSummary page 1…IAL EQUIVALENCE: Motion Concepts: TRx-CG Center of Gravity Shifting Power Tilt K981837 Mechanical Application Designs: ~ Tiltmaster Center of Gravity Power Tilt System K972564 Invacare Corporation. Tarsys Weight Shifting Basic Tilt System 16-1 7 4 DESCRIPTION: THE ACCELERATED REHAB DE… | 1997 |
| * | — | Invacare Corporation Tarsys Weight Shifting Basic Tilt System Named without a submission number |
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 |
|---|---|---|---|
| K050264 | Stealth Products Seating System | 2005 | 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?
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 "T-2000 Power Tilt System" is an aftermarket Power Tilt in Space Seating System utilizing the wheelchair manufactures base frame and seat frame. The T-2000 Power Tilt Seating System attaches between the base frame and seat frame of the wheelchair, allowing for the tilting 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 T-2000 system has no software based…
Read the full statement (208 words)
The "T-2000 Power Tilt System" is an aftermarket Power Tilt in Space Seating System utilizing the wheelchair manufactures base frame and seat frame. The T-2000 Power Tilt Seating System attaches between the base frame and seat frame of the wheelchair, allowing for the tilting 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 T-2000 system has no software based components. The T-2000 system is appropriate for individuals who requirg chances in position without the help of an attendant. Power tilt systems are utilizedby 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, Mechanical Application Designs, and Invacare Tarsys Power Tilt in Space 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/K992804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992804: T-2000-Power Tilt Seating System, Models Ard-Tstorm, Ard-TP-320, Ard-TG424, Ard-TS525, Ard-Tjazzy, Ard-Tlancer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992804
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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