510(k) · Cleared
ClearedBE-Mobile 4-Wheeled Electric Scooter, Model DK S500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tung Keng Enterprise Co., Ltd. · INI Vehicle, Motorized 3-Wheeled
Cleared on Nov 12, 2003 as substantially equivalent to K013763 (Wu'S Tech Co., Ltd., 2002) after a 37-day review. Its family tree reaches back 1 generation to 2002. 21 later devices descend from it.
- Decided
- Nov 12, 2003
- Review
- 37 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013763 (2002). 21 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK013763 Wu's 4-Wheeled Neo Scooter, WT-L4Wu'S Tech Co., Ltd. · 2002
- This deviceK033239 BE-Mobile 4-Wheeled Electric Scooter, Model DK S500Tung Keng Enterprise Co., Ltd. · 2003
- Descendant · cites it directly · 19 of its ownK043326 Bewell, Model SC 20Cycling and Health Tech. Industry R&D Center · 2005
- Descendant · 2 generations on · 12 of its ownK051538 Avanticare, Model SA4022Lerado China Limited · 2005
- Descendant · 3 generations on · 9 of its ownK072630 Foru, Model EQ30Kwang Yang Motor Co., Ltd. · 2007
- Descendant · 2 generations on · 2 of its ownK050793 Landlex Model S400XCycling and Health Tech. Industry R&D Center · 2005
- Descendant · 4 generations on · 1 of its ownK130940 Kymco EQ20C ScooterKwang Yang Motor Co., Ltd. · 2013
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K043326Bewell, Model SC 20Cycling and Health Tech. Industry R&D Center · 2005 · cites it directly19descendants
- K051538Avanticare, Model SA4022Lerado China Limited · 2005 · 2 generations on12descendants
- K072630Foru, Model EQ30Kwang Yang Motor Co., Ltd. · 2007 · 3 generations on9descendants
- K050793Landlex Model S400XCycling and Health Tech. Industry R&D Center · 2005 · 2 generations on2descendants
- K130940Kymco EQ20C ScooterKwang Yang Motor Co., Ltd. · 2013 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013763 | Wu's 4-Wheeled Neo Scooter, WT-L4 | Wu'S Tech Co., Ltd. | 2002 | — |
| 0 (this device) | K033239 | BE-Mobile 4-Wheeled Electric Scooter, Model DK S500 | Tung Keng Enterprise Co., Ltd. | 2003 | — |
| +1 | K043326 | Bewell, Model SC 20 | Cycling and Health Tech. Industry R&D Center | 2005 | — |
| +2 | K051538 | Avanticare, Model SA4022 | Lerado China Limited | 2005 | — |
| +3 | K072630 | Foru, Model EQ30 | Kwang Yang Motor Co., Ltd. | 2007 | — |
| +2 | K050793 | Landlex Model S400X | Cycling and Health Tech. Industry R&D Center | 2005 | — |
| +4 | K130940 | Kymco EQ20C Scooter | Kwang Yang Motor Co., Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 6 | 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 |
|---|---|---|---|
| * | K013763 | Wu's 4-Wheeled Neo Scooter, WT-L4Summary page 1…d their chargers - requirements and test methods) Legally marketed device for substantial equivalence comparison: WU'S 4-WHEELED N E 0 SCOOTER WT-L4 (K013763) TUNG KENG ENTERPRISE CO., LI 0.… | 2002 |
What descends from it? (21)
See all 212 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 piirposes to provide niobilitv to persons restricted to a sitting position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033239 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033239: BE-Mobile 4-Wheeled Electric Scooter, Model DK S500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033239
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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