510(k) · Cleared
ClearedAlante, Battery Operated Power Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Golden Technologies, Inc. · ITI Wheelchair, Powered
Cleared on May 29, 2001 after a 43-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 29, 2001
- Review
- 43 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK011153 Alante, Battery Operated Power WheelchairGolden Technologies, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK073686 C.T.M. Power Chair, Model HS-1500C.T.M. Homecare Product, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK173315 SupaChair Powered WheelchairEurogreen International, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK041341 Golden Spyder, Model GS-300Golden Technologies, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK202632 Electric wheelchair (S7204/S7205)Dongguan Prestige Sporting Goods Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK153636 Liberator Powered Wheelchair with Solar CompanionSolar Mobilityllc · 2016
Most influential descendants
Showing 5 of 5 · See all- K073686C.T.M. Power Chair, Model HS-1500C.T.M. Homecare Product, Inc. · 2008 · cites it directly2descendants
- K173315SupaChair Powered WheelchairEurogreen International, Inc. · 2018 · 2 generations on1descendant
- K041341Golden Spyder, Model GS-300Golden Technologies, Inc. · 2004 · cites it directly1descendant
- K202632Electric wheelchair (S7204/S7205)Dongguan Prestige Sporting Goods Co., Ltd. · 2021 · 3 generations on0descendants
- K153636Liberator Powered Wheelchair with Solar CompanionSolar Mobilityllc · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011153 | Alante, Battery Operated Power Wheelchair | Golden Technologies, Inc. | 2001 | — |
| +1 | K073686 | C.T.M. Power Chair, Model HS-1500 | C.T.M. Homecare Product, Inc. | 2008 | — |
| +2 | K173315 | SupaChair Powered Wheelchair | Eurogreen International, Inc. | 2018 | — |
| +1 | K041341 | Golden Spyder, Model GS-300 | Golden Technologies, Inc. | 2004 | — |
| +3 | K202632 | Electric wheelchair (S7204/S7205) | Dongguan Prestige Sporting Goods Co., Ltd. | 2021 | — |
| +2 | K153636 | Liberator Powered Wheelchair with Solar Companion | Solar Mobilityllc | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
2 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?
- Of its descendants, K073686 (C.T.M. Homecare Product, Inc., 2008) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K011153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011153: Alante, Battery Operated Power Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011153
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026