510(k) · Cleared
ClearedA&I Scooter, SC-402
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well Success Biotech, Inc. · INI Vehicle, Motorized 3-Wheeled
Cleared on May 25, 2004 as substantially equivalent to K032617 (Wu'S Tech Co., Ltd., 2003) after a 19-day review. Its family tree reaches back 2 generations to 2002. 2 later devices descend from it.
- Decided
- May 25, 2004
- Review
- 19 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013763 (2002). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK013763 Wu's 4-Wheeled Neo Scooter, WT-L4Wu'S Tech Co., Ltd. · 2002
- 1 generation backK032617 Wu's 4-Wheeled Scooter, WT-L4JRWu'S Tech Co., Ltd. · 2003
- This deviceK041193 A&I Scooter, SC-402Well Success Biotech, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK041677 Karma Scooter, Model KS-747.2Karma Medical Products Co., Ltd. · 2004
- Descendant · 2 generations on · 0 of its ownK261232 IERO Mobility Scooter (IERO-01)Jochu Technology Co., Ltd. · 2026
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 |
|---|---|---|---|---|---|
| −2 | K013763 | Wu's 4-Wheeled Neo Scooter, WT-L4 | Wu'S Tech Co., Ltd. | 2002 | — |
| −1 | K032617 | Wu's 4-Wheeled Scooter, WT-L4JR | Wu'S Tech Co., Ltd. | 2003 | — |
| 0 (this device) | K041193 | A&I Scooter, SC-402 | Well Success Biotech, Inc. | 2004 | — |
| +1 | K041677 | Karma Scooter, Model KS-747.2 | Karma Medical Products Co., Ltd. | 2004 | — |
| +2 | K261232 | IERO Mobility Scooter (IERO-01) | Jochu Technology Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K032617 | Wu's 4-Wheeled Scooter, WT-L4JRSummary page 1…ir chargers - requirements and test methods) Legally marketed device for substantial equivalence comparison: WU's 3-Wheeled Neo Scooter, WT-L4Jr (K032617) D1… | 2003 |
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 |
|---|---|---|---|
| K041677 | Karma Scooter, Model KS-747.2 | 2004 | 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?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K041677 (Karma Medical Products Co., Ltd., 2004) has gone furthest, with 1 descendant of its own.
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/K041193 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041193: A&I Scooter, SC-402.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041193
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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