510(k) Report

510(k) · Cleared

Cleared

Wu's 4-Wheeled Neo Scooter, WT-L4

K013763510(k) TraditionalCleared Jul 30, 2002259-day reviewClass II21 CFR 890.3800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wu'S Tech Co., Ltd. · INI Vehicle, Motorized 3-Wheeled

Cleared on Jul 30, 2002 after a 259-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 30 later devices descend from it.

Decided
Jul 30, 2002
Review
259 days
Class
Class II
Product code
INI
Recalls
None
Predicates
0

30 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2005: 7 descendants cleared2003: 5 descendants cleared2004: 2 descendants cleared2006: 2 descendants cleared2026: 1 descendant cleared2007: 4 descendants cleared2008: 4 descendants cleared2009: 1 descendant cleared2013: 1 descendant cleared2017: 2 descendants cleared2010: 1 descendant cleared200020052010201520202025
  1. This deviceK013763 Wu's 4-Wheeled Neo Scooter, WT-L4Wu'S Tech Co., Ltd. · 2002
  2. Descendant · cites it directly · 21 of its ownK033239 BE-Mobile 4-Wheeled Electric Scooter, Model DK S500Tung Keng Enterprise Co., Ltd. · 2003
  3. Descendant · 2 generations on · 19 of its ownK043326 Bewell, Model SC 20Cycling and Health Tech. Industry R&D Center · 2005
  4. Descendant · 3 generations on · 12 of its ownK051538 Avanticare, Model SA4022Lerado China Limited · 2005
  5. Descendant · 4 generations on · 9 of its ownK072630 Foru, Model EQ30Kwang Yang Motor Co., Ltd. · 2007
  6. Descendant · cites it directly · 3 of its ownK032617 Wu's 4-Wheeled Scooter, WT-L4JRWu'S Tech Co., Ltd. · 2003

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2003: 52004: 22005: 72006: 22007: 42008: 42009: 12010: 12013: 12017: 22026: 1
2003high 7 (2005) · low 0 (2011)2026

Most influential descendants

Showing 5 of 30 · See all
  • K033239BE-Mobile 4-Wheeled Electric Scooter, Model DK S500Tung Keng Enterprise Co., Ltd. · 2003 · cites it directly21descendants
  • K043326Bewell, Model SC 20Cycling and Health Tech. Industry R&D Center · 2005 · 2 generations on19descendants
  • K051538Avanticare, Model SA4022Lerado China Limited · 2005 · 3 generations on12descendants
  • K072630Foru, Model EQ30Kwang Yang Motor Co., Ltd. · 2007 · 4 generations on9descendants
  • K032617Wu's 4-Wheeled Scooter, WT-L4JRWu'S Tech Co., Ltd. · 2003 · cites it directly3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K013763Wu's 4-Wheeled Neo Scooter, WT-L4Wu'S Tech Co., Ltd.2002—
+1K033239BE-Mobile 4-Wheeled Electric Scooter, Model DK S500Tung Keng Enterprise Co., Ltd.2003—
+2K043326Bewell, Model SC 20Cycling and Health Tech. Industry R&D Center2005—
+3K051538Avanticare, Model SA4022Lerado China Limited2005—
+4K072630Foru, Model EQ30Kwang Yang Motor Co., Ltd.2007—
+1K032617Wu's 4-Wheeled Scooter, WT-L4JRWu'S Tech Co., Ltd.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200350
200420
200570
200620
200740
200840
200910
201010
201310
201720
202610
FIG. 1 — Lineage of K013763, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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. #1 K231428 Mobility Scooter (Models: W3431D)score 23.1 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (30)

See all 30

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033239BE-Mobile 4-Wheeled Electric Scooter, Model DK S500Tung Keng Enterprise Co., Ltd.200321
K032617Wu's 4-Wheeled Scooter, WT-L4JRWu'S Tech Co., Ltd.20033
K050042Wu's 4-Wheeled Neo Scooter, WT-XL4Wu'S Tech Co., Ltd.20050
K033220BE-Mobile 4-Wheeled Electric Scooter, Model DK S280Tung Keng Enterprise Co., Ltd.20030
K033219BE-Mobile 4-Wheeled Electric Scooter, Model DK S600Tung Keng Enterprise Co., Ltd.20030
K033204Esg 4-Wheel Scooter, Esg-03Emg Technology Co., Ltd.20030

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, K033239 (Tung Keng Enterprise Co., Ltd., 2003) has gone furthest, with 21 descendants of its own.

How does its category compare?

All INI devices

INI 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

2007: 182008: 72009: 122010: 52011: 52012: 12013: 22014: 12015: 92016: 12017: 52018: 32019: 42020: 12021: 52022: 62023: 92024: 82025: 152026 (partial year): 21
2007high 21 (2026) · low 1 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · INI

111in 2025

2007: 29 days median2008: 28 days median2009: 41 days median2010: 46 days median2011: 130 days median2015: 202 days median2017: 191 days median2018: 266 days median2019: 298 days median2021: 575 days median2022: 159 days median2023: 123 days median2024: 137 days median2025: 111 days median2026 (partial year): 108 days median
2007high 575 (2021) · low 28 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · INI

1in 2013

2007: 22010: 32011: 32013: 1
2007high 3 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · INI

26in 2025

2007: 642008: 292009: 252010: 562011: 702012: 1722013: 4542014: 5672015: 1512016: 762017: 452018: 512019: 252020: 262021: 412022: 412023: 322024: 312025: 26
2007high 567 (2014) · low 25 (2009)2025

MAUDE reports naming product code INI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071829264
2008728029
20091241025
2010546356
20115130370
20121—0172
20132—1454
20141—0567
201592020151
20161—076
20175191045
20183266051
20194298025
20201—026
20215575041
20226159041
20239123032
20248137031
202515111026
2026211080—

What is it indicated for?

The device is iiiferiden for iiredicnl purposes lo provide mobility to persotts restricted to n seated position.

Indications for use as stated in the FDA 510(k) statement.

Cite this page

510(k) Report. “K013763: Wu's 4-Wheeled Neo Scooter, WT-L4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013763

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026