510(k) · Cleared
ClearedBewell, Model SC 20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cycling and Health Tech. Industry R&D Center · INI Vehicle, Motorized 3-Wheeled
Cleared on Jan 26, 2005 as substantially equivalent to K033239 (Tung Keng Enterprise Co., Ltd., 2003) after a 55-day review. Its family tree reaches back 2 generations to 2002. 19 later devices descend from it.
- Decided
- Jan 26, 2005
- Review
- 55 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013763 (2002). 19 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK013763 Wu's 4-Wheeled Neo Scooter, WT-L4Wu'S Tech Co., Ltd. · 2002
- 1 generation backK033239 BE-Mobile 4-Wheeled Electric Scooter, Model DK S500Tung Keng Enterprise Co., Ltd. · 2003
- This deviceK043326 Bewell, Model SC 20Cycling and Health Tech. Industry R&D Center · 2005
- Descendant · cites it directly · 12 of its ownK051538 Avanticare, Model SA4022Lerado China Limited · 2005
- Descendant · 2 generations on · 9 of its ownK072630 Foru, Model EQ30Kwang Yang Motor Co., Ltd. · 2007
- Descendant · cites it directly · 2 of its ownK050793 Landlex Model S400XCycling and Health Tech. Industry R&D Center · 2005
- Descendant · 3 generations on · 1 of its ownK130940 Kymco EQ20C ScooterKwang Yang Motor Co., Ltd. · 2013
- Descendant · 2 generations on · 1 of its ownK082901 Kymco Foru, Model EQ20Kwang Yang Motor Co., Ltd. · 2008
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K051538Avanticare, Model SA4022Lerado China Limited · 2005 · cites it directly12descendants
- K072630Foru, Model EQ30Kwang Yang Motor Co., Ltd. · 2007 · 2 generations on9descendants
- K050793Landlex Model S400XCycling and Health Tech. Industry R&D Center · 2005 · cites it directly2descendants
- K130940Kymco EQ20C ScooterKwang Yang Motor Co., Ltd. · 2013 · 3 generations on1descendant
- K082901Kymco Foru, Model EQ20Kwang Yang Motor Co., Ltd. · 2008 · 2 generations on1descendant
View 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 | K033239 | BE-Mobile 4-Wheeled Electric Scooter, Model DK S500 | Tung Keng Enterprise Co., Ltd. | 2003 | — |
| 0 (this device) | K043326 | Bewell, Model SC 20 | Cycling and Health Tech. Industry R&D Center | 2005 | — |
| +1 | K051538 | Avanticare, Model SA4022 | Lerado China Limited | 2005 | — |
| +2 | K072630 | Foru, Model EQ30 | Kwang Yang Motor Co., Ltd. | 2007 | — |
| +1 | K050793 | Landlex Model S400X | Cycling and Health Tech. Industry R&D Center | 2005 | — |
| +3 | K130940 | Kymco EQ20C Scooter | Kwang Yang Motor Co., Ltd. | 2013 | — |
| +2 | K082901 | Kymco Foru, Model EQ20 | Kwang Yang Motor Co., Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K033239 | BE-Mobile 4-Wheeled Electric Scooter, Model DK S500Summary page 1…Classification: Class 11 Predicate devices Manufacture name: TUNG DENG ENTERPRISE CO., LTD. Name: Be-Mobile 4-Wheeled Electric Scooter, DK S500 k number: K033239 Date cleared: 12/18/2003 Intend use of device Bewell SC 20 scooter is intended for an indoor/outdoor scooter that provide… | 2003 |
What descends from it? (19)
See all 196 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?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K051538 (Lerado China Limited, 2005) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K033239.
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 Bewell SC 20 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043326 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043326: Bewell, Model SC 20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043326
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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