510(k) · Cleared
ClearedFreerider Model Luggie Model 168-4IT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Freerider Luggie Scooters, Inc. · INI Vehicle, Motorized 3-Wheeled
Cleared on Sep 30, 2011 after a 254-day review. The FDA summary names its predicate without a number. 49 later devices descend from it.
- Decided
- Sep 30, 2011
- Review
- 254 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 0
49 later devices descend from it, 4 citing it directly.
- This deviceK110165 Freerider Model Luggie Model 168-4ITFreerider Luggie Scooters, Inc. · 2011
- Descendant · cites it directly · 40 of its ownK122749 Prestige-MobiePrestige Sporting Goods Co., Ltd. · 2012
- Descendant · 2 generations on · 38 of its ownK172440 Solax Electric Scooter, Models: S302121, S302131, S302141, S302151Dongguan Prestige Sporting Goods., Ltd. · 2018
- Descendant · 3 generations on · 34 of its ownK182471 ScooterTianjin Kepler Vehicle Industry Co., Ltd. · 2019
- Descendant · 4 generations on · 19 of its ownK220206 Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022
- Descendant · 5 generations on · 12 of its ownK222507 Mobility Scooter (Models: W3431Q, W3431R)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K122749Prestige-MobiePrestige Sporting Goods Co., Ltd. · 2012 · cites it directly40descendants
- K172440Solax Electric Scooter, Models: S302121, S302131, S302141, S302151Dongguan Prestige Sporting Goods., Ltd. · 2018 · 2 generations on38descendants
- K182471ScooterTianjin Kepler Vehicle Industry Co., Ltd. · 2019 · 3 generations on34descendants
- K220206Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022 · 4 generations on19descendants
- K222507Mobility Scooter (Models: W3431Q, W3431R)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K110165 | Freerider Model Luggie Model 168-4IT | Freerider Luggie Scooters, Inc. | 2011 | — |
| +1 | K122749 | Prestige-Mobie | Prestige Sporting Goods Co., Ltd. | 2012 | — |
| +2 | K172440 | Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 | Dongguan Prestige Sporting Goods., Ltd. | 2018 | — |
| +3 | K182471 | Scooter | Tianjin Kepler Vehicle Industry Co., Ltd. | 2019 | — |
| +4 | K220206 | Mobility Scooter | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022 | — |
| +5 | K222507 | Mobility Scooter (Models: W3431Q, W3431R) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 4 | 0 |
| 2025 | 9 | 0 |
| 2026 | 13 | 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 |
|---|---|---|---|
| * | — | Tzora Active Systems Ltd -Easy Travel Elite Named without a submission number |
What descends from it? (49)
See all 494 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?
- Of its descendants, K122749 (Prestige Sporting Goods Co., Ltd., 2012) has gone furthest, with 40 descendants of its own.
How does its category compare?
All INI devicesINI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 Freerider Model Luggie is a motorized scooter which provides transportation for an elderly or disabled person. It can be in a variety of indoor and outdoor settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110165 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110165: Freerider Model Luggie Model 168-4IT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110165
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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