510(k) · Cleared
ClearedLuggie Super
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Freerider Corporation · INI Vehicle, Motorized 3-Wheeled
Cleared on Sep 10, 2015 as substantially equivalent to K110165 (Freerider Luggie Scooters, Inc., 2011) after a 58-day review. Its family tree reaches back 1 generation to 2011. 3 later devices descend from it.
- Decided
- Sep 10, 2015
- Review
- 58 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K110165 (2011). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK110165 Freerider Model Luggie Model 168-4ITFreerider Luggie Scooters, Inc. · 2011
- This deviceK151944 Luggie SuperFreerider Corporation · 2015
- Descendant · cites it directly · 0 of its ownK192885 C.T.M. Mobility Scooter HS-268Chien TI Enterprise Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK181344 C.T.M Mobility ScooterChien TI Enterprise Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK160139 Luggie ChairFreerider Corporation · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K110165 | Freerider Model Luggie Model 168-4IT | Freerider Luggie Scooters, Inc. | 2011 | — |
| 0 (this device) | K151944 | Luggie Super | Freerider Corporation | 2015 | — |
| +1 | K192885 | C.T.M. Mobility Scooter HS-268 | Chien TI Enterprise Co., Ltd. | 2019 | — |
| +1 | K181344 | C.T.M Mobility Scooter | Chien TI Enterprise Co., Ltd. | 2018 | — |
| +1 | K160139 | Luggie Chair | Freerider Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 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 |
|---|---|---|---|
| * | K110165 | Freerider Model Luggie Model 168-4ITSummary page 4…scooter Classification Name: Motorized three-wheeled vehicle; INI; 890.3800 3. Legally Marketed Predicate Device(s) 510(k) Number Product Code Trade Name Manufacturer K110165 INI Freerider FR 168-4(IT) Freerider Corp. Luggie 4. Device Description The FR-LO5 (Luggie Super) is a battery-powered, three-wh… | 2011 |
What descends from it? (3)
3 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?
How does its category compare?
All INI devicesINI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 FR-L05 (Luggie Super) provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151944 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151944: Luggie Super.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151944
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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