510(k) · Cleared
ClearedQuingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Vehicle Concepts, Ltd. · INI Vehicle, Motorized 3-Wheeled
Cleared on Nov 29, 2017 as substantially equivalent to K142162 (Merits Health Products Co., Ltd., 2015) after a 272-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Nov 29, 2017
- Review
- 272 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011753 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK011753 Travel Ease Electric Scooter, Model Pioneer 4Merits Health Products., Inc. · 2001 · Recalled
- 1 generation backK142162 Merits Transformer Power Scooter, S941Merits Health Products Co., Ltd. · 2015 · Recalled
- This deviceK170634 Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551…Advanced Vehicle Concepts, Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011753 | Travel Ease Electric Scooter, Model Pioneer 4 | Merits Health Products., Inc. | 2001 | 1 |
| −1 | K142162 | Merits Transformer Power Scooter, S941 | Merits Health Products Co., Ltd. | 2015 | 1 |
| 0 (this device) | K170634 | Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo… | Advanced Vehicle Concepts, Ltd. | 2017 | — |
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 |
|---|---|---|---|
| * | K142162 | Merits Transformer Power Scooter, S941Summary page 4…Product Code: INI Classification Panel: Physical Medicine 3. Predicate Device: Merits Health Products Co., Ltd., Merits Transformer, Model S941, K142162 1 4. Device Description . There are three models in th… | 2015 |
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 16 years and passes through 3 companies; a new generation was cleared every 13.7 years on median.
- 2 of the 2 ancestors have a recall of any class.
How does its category compare?
All INI devicesINI 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
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 devices provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170634: Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170634
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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