510(k) · Cleared
ClearedComfort Scooter, Model LY-EW415
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Comfort Orthopedic Co., Ltd. · INI Vehicle, Motorized 3-Wheeled
Cleared on Oct 16, 2006 as substantially equivalent to K022369 (Comfort Orthopedic Co., Ltd., 2002) after a 13-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Oct 16, 2006
- Review
- 13 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022369 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK022369 Comfort Windjoy Scooter, Model LY-EW302Comfort Orthopedic Co., Ltd. · 2002
- This deviceK063032 Comfort Scooter, Model LY-EW415Comfort Orthopedic Co., Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK072712 Comfort Electric Scooter, LY-EW408Comfort Orthopedic Co., Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK070817 Leradotech Scooter, Model SBLerado China Limited · 2007
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 | K022369 | Comfort Windjoy Scooter, Model LY-EW302 | Comfort Orthopedic Co., Ltd. | 2002 | — |
| 0 (this device) | K063032 | Comfort Scooter, Model LY-EW415 | Comfort Orthopedic Co., Ltd. | 2006 | — |
| +1 | K072712 | Comfort Electric Scooter, LY-EW408 | Comfort Orthopedic Co., Ltd. | 2007 | — |
| +1 | K070817 | Leradotech Scooter, Model SB | Lerado China Limited | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 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 INI? 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 INI device
- #1 K231428 Mobility Scooter (Models: W3431D)score 23.1 · 9 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 |
|---|---|---|---|
| * | K022369 | Comfort Windjoy Scooter, Model LY-EW302Summary page 1…d thei[ chargers - requirements and test met hods) Legally marketed device for substantial equivwilence comparison: COMFORT WINDJOY SCOOTER LY-EW302 (K022369) eCOmFORT COMFORT ORTHOPEDIC CO., LTD. www.comfort.com.tw No.120,Nan Shiang Tsuen,Shoei Shang Shiang,Chia-yi,Taiw… | 2002 |
What descends from it? (2)
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?
How does its category compare?
All INI devicesINI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · INI
21so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · INI
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · INI
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · INI
26in 2025
MAUDE reports naming product code INI, 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 | 29 | 2 | 64 |
| 2008 | 7 | 28 | 0 | 29 |
| 2009 | 12 | 41 | 0 | 25 |
| 2010 | 5 | 46 | 3 | 56 |
| 2011 | 5 | 130 | 3 | 70 |
| 2012 | 1 | — | 0 | 172 |
| 2013 | 2 | — | 1 | 454 |
| 2014 | 1 | — | 0 | 567 |
| 2015 | 9 | 202 | 0 | 151 |
| 2016 | 1 | — | 0 | 76 |
| 2017 | 5 | 191 | 0 | 45 |
| 2018 | 3 | 266 | 0 | 51 |
| 2019 | 4 | 298 | 0 | 25 |
| 2020 | 1 | — | 0 | 26 |
| 2021 | 5 | 575 | 0 | 41 |
| 2022 | 6 | 159 | 0 | 41 |
| 2023 | 9 | 123 | 0 | 32 |
| 2024 | 8 | 137 | 0 | 31 |
| 2025 | 15 | 111 | 0 | 26 |
| 2026 | 21 | 108 | 0 | — |
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 summary.
https://510kreport.com/device/K063032 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063032: Comfort Scooter, Model LY-EW415.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063032
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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