510(k) Report

510(k) · Cleared

Cleared

Electrical Scooter, WT-T4QP2

K222729510(k) TraditionalCleared Mar 28, 2023201-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 Mar 28, 2023 as substantially equivalent to K191356 (Puc Perfect Union Co., Ltd., 2022) after a 201-day review. Its family tree reaches back 5 generations to 2003. 1 later device descends from it.

Decided
Mar 28, 2023
Review
201 days
Class
Class II
Product code
INI
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K032488 (2003). 1 later device descends from it, 1 citing it directly.

  1. Root · 5 generations backK032488 Wu's 3-Wheeled Neo Scooter, WT-T3DWu'S Tech Co., Ltd. · 2003
  2. 4 generations backK071007 Heartway Lightweight Power Mobility Scooter, S33Heartway Medical Products Co., Ltd. · 2007
  3. 3 generations backK101142 Heartway Lightweight Power Mobility Scooter, S34Heartway Medical Products Co., Ltd. · 2010
  4. 2 generations backK150987 HEARTWAY Power Mobility Scooter, BRIO S19Heartway Medical Products Co., Ltd. · 2015
  5. 1 generation backK191356 i3 Foldable Mobility ScooterPuc Perfect Union Co., Ltd. · 2022
  6. This deviceK222729 Electrical Scooter, WT-T4QP2Wu’S Tech Co., Ltd. · 2023
  7. Descendant · cites it directly · 0 of its ownK240590 Electrical Scooter, WT-T4SUW'U'S Tech Co., Ltd. · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K240590Electrical Scooter, WT-T4SUW'U'S Tech Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K032488Wu's 3-Wheeled Neo Scooter, WT-T3DWu'S Tech Co., Ltd.2003—
−4K071007Heartway Lightweight Power Mobility Scooter, S33Heartway Medical Products Co., Ltd.2007—
−3K101142Heartway Lightweight Power Mobility Scooter, S34Heartway Medical Products Co., Ltd.2010—
−2K150987HEARTWAY Power Mobility Scooter, BRIO S19Heartway Medical Products Co., Ltd.2015—
−1K191356i3 Foldable Mobility ScooterPuc Perfect Union Co., Ltd.2022—
0 (this device)K222729Electrical Scooter, WT-T4QP2Wu’S Tech Co., Ltd.2023—
+1K240590Electrical Scooter, WT-T4SUW'U'S Tech Co., Ltd.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K222729, 2003–2025Source: 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 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. #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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K191356i3 Foldable Mobility Scooter
Summary page 4
…TEL: 886-3-5208829 Predicate Device PUC Perfect Union Co., Ltd. Device name i3 Foldable Mobility Scooter 510(k) Number K191356 Indications for Use: The device is intended for medical purposes to provide mobility to persons restricted to a sittin…
Puc Perfect Union Co., Ltd.2022—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K240590Electrical Scooter, WT-T4SUW'U'S Tech Co., Ltd.20250

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 20 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K240590 (W'U'S Tech Co., Ltd., 2025) has gone furthest, with 0 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. 2023, this device’s year, is highlighted.

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 intended for medical purposes to provide mobility to persons restricted to a sitting position.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K222729: Electrical Scooter, WT-T4QP2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222729

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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