510(k) Report

510(k) · Cleared

Cleared

Quingo Flyte Mobility Scooter

K171256510(k) TraditionalCleared Jun 8, 201741-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

Agile Distributors, LLC · INI Vehicle, Motorized 3-Wheeled

Cleared on Jun 8, 2017 as substantially equivalent to K072630 (Kwang Yang Motor Co., Ltd., 2007) after a 41-day review. Its family tree reaches back 5 generations to 2002.

Decided
Jun 8, 2017
Review
41 days
Class
Class II
Product code
INI
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K013763 (2002). No later device cites it as a predicate yet.

  1. Root · 5 generations backK013763 Wu's 4-Wheeled Neo Scooter, WT-L4Wu'S Tech Co., Ltd. · 2002
  2. 4 generations backK033239 BE-Mobile 4-Wheeled Electric Scooter, Model DK S500Tung Keng Enterprise Co., Ltd. · 2003
  3. 3 generations backK043326 Bewell, Model SC 20Cycling and Health Tech. Industry R&D Center · 2005
  4. 2 generations backK051538 Avanticare, Model SA4022Lerado China Limited · 2005
  5. 1 generation backK072630 Foru, Model EQ30Kwang Yang Motor Co., Ltd. · 2007
  6. This deviceK171256 Quingo Flyte Mobility ScooterAgile Distributors, LLC · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K013763Wu's 4-Wheeled Neo Scooter, WT-L4Wu'S Tech Co., Ltd.2002—
−4K033239BE-Mobile 4-Wheeled Electric Scooter, Model DK S500Tung Keng Enterprise Co., Ltd.2003—
−3K043326Bewell, Model SC 20Cycling and Health Tech. Industry R&D Center2005—
−2K051538Avanticare, Model SA4022Lerado China Limited2005—
−1K072630Foru, Model EQ30Kwang Yang Motor Co., Ltd.2007—
0 (this device)K171256Quingo Flyte Mobility ScooterAgile Distributors, LLC2017—
FIG. 1 — Lineage of K171256, 2002–2017Source: 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
*K072630Foru, Model EQ30
Summary page 4
…ate device for substantial equivalence comparison is:  Kymco EQ 30, manufactured and distributed by Kwang Yang Motor Company Ltd., and cleared under 501(k) K072630 Description of the Device: The Quingo Flyte Mobility Scooter is a battery powered indoor and outdoor scooter. The vehicle use…
Kwang Yang Motor Co., Ltd.2007—

Also cleared against K072630: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 15 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
  • None of the 5 ancestors has a recall.
  • 6 other devices also cite its predicate K072630.

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. 2017, 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 Quingo Flyte is an electric scooter designed to provide transportation to those with mobility limitations such as the disabled or elderly.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K171256: Quingo Flyte Mobility Scooter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K171256

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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