510(k) · Cleared
ClearedComfort Powered Wheelchair, Traveller LY-EB 103
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Comfort Orthopedic Co., Ltd. · ITI Wheelchair, Powered
Cleared on May 20, 2003 after a 106-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- May 20, 2003
- Review
- 106 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK030356 Comfort Powered Wheelchair, Traveller LY-EB 103Comfort Orthopedic Co., Ltd. · 2003
- Descendant · cites it directly · 1 of its ownK033100 Taiwan King Strong Powered Wheelchair, TP 01Taiwan King Strong Co., Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK202506 Karma Powered WheelchairKarma Medical Products Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK072711 Comfort Powered Wheelchair, LY-EB 206Comfort Orthopedic Co., Ltd. · 2007
- Descendant · 2 generations on · 0 of its ownK050011 Wu's Powered Wheelchair, Mambo F 120Wu'S Tech Co., Ltd. · 2005
Most influential descendants
Showing 4 of 4 · See all- K033100Taiwan King Strong Powered Wheelchair, TP 01Taiwan King Strong Co., Ltd. · 2003 · cites it directly1descendant
- K202506Karma Powered WheelchairKarma Medical Products Co., Ltd. · 2021 · cites it directly0descendants
- K072711Comfort Powered Wheelchair, LY-EB 206Comfort Orthopedic Co., Ltd. · 2007 · cites it directly0descendants
- K050011Wu's Powered Wheelchair, Mambo F 120Wu'S Tech Co., Ltd. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030356 | Comfort Powered Wheelchair, Traveller LY-EB 103 | Comfort Orthopedic Co., Ltd. | 2003 | — |
| +1 | K033100 | Taiwan King Strong Powered Wheelchair, TP 01 | Taiwan King Strong Co., Ltd. | 2003 | — |
| +1 | K202506 | Karma Powered Wheelchair | Karma Medical Products Co., Ltd. | 2021 | — |
| +1 | K072711 | Comfort Powered Wheelchair, LY-EB 206 | Comfort Orthopedic Co., Ltd. | 2007 | — |
| +2 | K050011 | Wu's Powered Wheelchair, Mambo F 120 | Wu'S Tech Co., Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
3 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, K033100 (Taiwan King Strong Co., Ltd., 2003) 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 device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K030356 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030356: Comfort Powered Wheelchair, Traveller LY-EB 103.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030356
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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