510(k) · Cleared
ClearedE-2000 Power Elevating Seat System, Models Ard-Estorm, Ard-EP320, Ard-Elancer
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 K972563 (Mechanical Application Designs, Inc., 1997) after a 164-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Feb 3, 2000
- Review
- 164 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972563 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK972563 Lift MasterMechanical Application Designs, Inc. · 1997
- This deviceK992828 E-2000 Power Elevating Seat System, Models Ard-Estorm, Ard-EP320…Accelerated Rehab Designs, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK013516 Invacare Elevating Seat Option ESS6Invacare Corp. · 2001
- Descendant · 2 generations on · 0 of its ownK033819 Invacare 3G TarsysInvacare Corp. · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972563 | Lift Master | Mechanical Application Designs, Inc. | 1997 | — |
| 0 (this device) | K992828 | E-2000 Power Elevating Seat System, Models Ard-Estorm, Ard-EP320, Ard-Elancer | Accelerated Rehab Designs, Inc. | 2000 | — |
| +1 | K013516 | Invacare Elevating Seat Option ESS6 | Invacare Corp. | 2001 | — |
| +2 | K033819 | Invacare 3G Tarsys | Invacare Corp. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K972563 | Lift MasterSummary page 1…al Medicine / Wheelchair, Powered PRODUCT CODE: ITI REGULATION No: 890.3930 TYPE: Traditional SUBSTANCIAL EQUIVALENCE: Mechanical Application Designs, Inc: Liftmaster K972563 DESCRIPTION: THE ACCELERATED REHAB DESIGNS, INC “E-2000 POWER ELEVATING SEAT SYSTEM® CONSISTS OF A MOTION SYSTEM,… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013516 | Invacare Elevating Seat Option ESS6 | 2001 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K013516 (Invacare Corp., 2001) 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 “E-2000 Power Tilt Seating System” is an elevating system utilizing the wheelchair manufactures existing tubular seating system with armrests, front rigging, back assembly, and optional accessories. The Elevating Seat System attaches to the wheelchair base frame and seat frame. 8y activation of the supplied switch, the system will elevate up to eight (8) inches from its lowest position. The E-2000 Power Elevating Seat System aflows the customer the…
Read the full statement (222 words)
The “E-2000 Power Tilt Seating System” is an elevating system utilizing the wheelchair manufactures existing tubular seating system with armrests, front rigging, back assembly, and optional accessories.
The Elevating Seat System attaches to the wheelchair base frame and seat frame. 8y activation of the supplied switch, the system will elevate up to eight (8) inches from its lowest position.
The E-2000 Power Elevating Seat System aflows the customer the availability to reach items that in the past, were unreachable to them due to their physical limitations. In the home, the overhead kitchen cabinets are now accessible. In the workplace, the availability of reaching the upper drawers of file cabinets without help from others. Having the ability to interact with fellow students on their level, within the school setting. Some of the customers that may benefit from the use of the E-2000 System are customers with a diagnosis of,, but not limited to:
Muscular Dystrophy (MD)
Multiple Sclerosis (MS)
Spinal Cord Injury (SCI)
Amyotrophic Lateral Sclerosis (ALS)
e
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 Mechanical Application Designs, Inc Liftmaster System in which 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/K992828 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992828: E-2000 Power Elevating Seat System, Models Ard-Estorm, Ard-EP320, Ard-Elancer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992828
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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