510(k) · Cleared
ClearedSolax Electric Scooter, Models: S302121, S302131, S302141, S302151
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dongguan Prestige Sporting Goods., Ltd. · INI Vehicle, Motorized 3-Wheeled
Cleared on Jul 13, 2018 as substantially equivalent to K122749 (Prestige Sporting Goods Co., Ltd., 2012) after a 336-day review. Its family tree reaches back 2 generations to 2011. 38 later devices descend from it.
- Decided
- Jul 13, 2018
- Review
- 336 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K110165 (2011). 38 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK110165 Freerider Model Luggie Model 168-4ITFreerider Luggie Scooters, Inc. · 2011
- 1 generation backK122749 Prestige-MobiePrestige Sporting Goods Co., Ltd. · 2012
- This deviceK172440 Solax Electric Scooter, Models: S302121, S302131, S302141, S302151Dongguan Prestige Sporting Goods., Ltd. · 2018
- Descendant · cites it directly · 34 of its ownK182471 ScooterTianjin Kepler Vehicle Industry Co., Ltd. · 2019
- Descendant · 2 generations on · 19 of its ownK220206 Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022
- Descendant · 3 generations on · 12 of its ownK222507 Mobility Scooter (Models: W3431Q, W3431R)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023
- Descendant · 4 generations on · 11 of its ownK231428 Mobility Scooter (Models: W3431D)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023
- Descendant · cites it directly · 7 of its ownK201196 Scooter (Model: FDB01)Nanjing Jin Bai HE Medical Apparatus Co., Ltd. · 2021
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K182471ScooterTianjin Kepler Vehicle Industry Co., Ltd. · 2019 · cites it directly34descendants
- K220206Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022 · 2 generations on19descendants
- K222507Mobility Scooter (Models: W3431Q, W3431R)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023 · 3 generations on12descendants
- K231428Mobility Scooter (Models: W3431D)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023 · 4 generations on11descendants
- K201196Scooter (Model: FDB01)Nanjing Jin Bai HE Medical Apparatus Co., Ltd. · 2021 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K110165 | Freerider Model Luggie Model 168-4IT | Freerider Luggie Scooters, Inc. | 2011 | — |
| −1 | K122749 | Prestige-Mobie | Prestige Sporting Goods Co., Ltd. | 2012 | — |
| 0 (this device) | K172440 | Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 | Dongguan Prestige Sporting Goods., Ltd. | 2018 | — |
| +1 | K182471 | Scooter | Tianjin Kepler Vehicle Industry Co., Ltd. | 2019 | — |
| +2 | K220206 | Mobility Scooter | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022 | — |
| +3 | K222507 | Mobility Scooter (Models: W3431Q, W3431R) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023 | — |
| +4 | K231428 | Mobility Scooter (Models: W3431D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023 | — |
| +1 | K201196 | Scooter (Model: FDB01) | Nanjing Jin Bai HE Medical Apparatus Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 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 |
|---|---|---|---|
| * | K122749 | Prestige-MobieSummary page 5…Dongguan Prestige Sporting Goods Co., Ltd. Device Name MOBIE scooter 510(k) Number K122749 Product Code INI Regulation Number 890.3800 Regulation Class 2 5… | 2012 |
What descends from it? (38)
See all 384 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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K182471 (Tianjin Kepler Vehicle Industry Co., Ltd., 2019) has gone furthest, with 34 descendants of its own.
- 1 other device also cites its predicate K122749.
How does its category compare?
All INI devicesINI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172440 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172440: Solax Electric Scooter, Models: S302121, S302131, S302141, S302151.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172440
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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