510(k) · Cleared
Recalled · 2010Electric Mobility Rascal and Chauffer Scooters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electric Mobility Corp. · INI Vehicle, Motorized 3-Wheeled
Cleared on Dec 11, 2000 after a 111-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 4 times.
- Decided
- Dec 11, 2000
- Review
- 111 days
- Class
- Class II
- Product code
- INI
- Recalls
- 4
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2010 | Not classified | Z-0417-2011 | Device Design | Scooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose and causing the seat to wobble. This may result in complete failure of the seat base, causing the user to fall off the vehicle. |
| Sep 27, 2010 | Not classified | Z-0415-2011 | Device Design | Scooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose and causing the seat to wobble. This may result in complete failure of the seat base, causing the user to fall off the vehicle. |
| Sep 27, 2010 | Not classified | Z-0416-2011 | Device Design | Scooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose and causing the seat to wobble. This may result in complete failure of the seat base, causing the user to fall off the vehicle. |
| Apr 17, 2006 | Not classified | Z-0903-06 | Other | The four seat mast mounting screws can loosen, causing seat to wobble. The chair seat actuator and portions of the seat can malfunction and/or break. Firm is aware of problems with the seat and injuries sustained from the powered… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All INI devicesINI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K002616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002616: Electric Mobility Rascal and Chauffer Scooters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002616
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026