510(k) · Cleared
ClearedInvacare Elevating Seat Option ESS6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corp. · ITI Wheelchair, Powered
Cleared on Dec 13, 2001 as substantially equivalent to K992828 (Accelerated Rehab Designs, Inc., 2000) after a 51-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Dec 13, 2001
- Review
- 51 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972563 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK972563 Lift MasterMechanical Application Designs, Inc. · 1997
- 1 generation backK992828 E-2000 Power Elevating Seat System, Models Ard-Estorm, Ard-EP320…Accelerated Rehab Designs, Inc. · 2000
- This deviceK013516 Invacare Elevating Seat Option ESS6Invacare Corp. · 2001
- Descendant · cites it directly · 0 of its ownK033819 Invacare 3G TarsysInvacare Corp. · 2004
Most influential descendants
Showing 1 of 1 · See all- K033819Invacare 3G TarsysInvacare Corp. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972563 | Lift Master | Mechanical Application Designs, Inc. | 1997 | — |
| −1 | K992828 | E-2000 Power Elevating Seat System, Models Ard-Estorm, Ard-EP320, Ard-Elancer | Accelerated Rehab Designs, Inc. | 2000 | — |
| 0 (this device) | K013516 | Invacare Elevating Seat Option ESS6 | Invacare Corp. | 2001 | — |
| +1 | K033819 | Invacare 3G Tarsys | Invacare Corp. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K992828 | E-2000 Power Elevating Seat System, Models Ard-Estorm, Ard-EP320, Ard-ElancerSummary page 1…-4558 Common or Usual Name Elevating Seat Classification Name Wheelchair, Powered Predicate Devices Accelerated Rehab Designs, Inc. “E-2000 Power Elevating Seat System” (K992828, 2/3/2000) Intended Use The intended function and use of the Invacare Elevating Seat is to provide powered elevation of the whee… | 2000 |
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 |
|---|---|---|---|
| K033819 | Invacare 3G Tarsys | 2004 | 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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K033819 (Invacare Corp., 2004) has gone furthest, with 0 descendants 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 intended function and use of the Invacare Elevating Seat is to provide powered elevation of the wheelchair seat and user in order to assist the user with daily activities, transfers and general accessibility..
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/K013516 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013516: Invacare Elevating Seat Option ESS6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013516
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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