510(k) · Cleared
Recalled · 2006Rascal Power Chair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electric Mobility Corp. · ITI Wheelchair, Powered
Cleared on Nov 14, 1997 after a 142-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Nov 14, 1997
- Review
- 142 days
- Class
- Class II
- Product code
- ITI
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ITI? 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 ITI device
- #1 K220747 Power Wheelchair (N5515B)score 40.2 · 4 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’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|---|
| 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 ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITI
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITI
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITI
13so far in 2026, the most since 2007
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · ITI
647in 2025
MAUDE reports naming product code ITI, 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 | 42 | 3 | 123 |
| 2008 | 9 | 49 | 3 | 133 |
| 2009 | 7 | 63 | 1 | 183 |
| 2010 | 6 | 46 | 2 | 157 |
| 2011 | 4 | 101 | 0 | 525 |
| 2012 | 6 | 155 | 1 | 2,919 |
| 2013 | 5 | 177 | 0 | 8,741 |
| 2014 | 5 | 213 | 0 | 7,282 |
| 2015 | 10 | 174 | 0 | 4,685 |
| 2016 | 6 | 173 | 1 | 1,575 |
| 2017 | 4 | 159 | 2 | 301 |
| 2018 | 4 | 117 | 0 | 273 |
| 2019 | 3 | 244 | 0 | 264 |
| 2020 | 6 | 278 | 0 | 205 |
| 2021 | 13 | 209 | 3 | 166 |
| 2022 | 16 | 96 | 0 | 135 |
| 2023 | 8 | 128 | 0 | 223 |
| 2024 | 38 | 125 | 1 | 146 |
| 2025 | 29 | 90 | 3 (2) | 647 |
| 2026 | 36 | 108 | 13 | — |
What is it indicated for?
The Electric Mobility RASCAL Power Wheelchair is intended to serve the needs of individuals who have very limited mobility and a reduced capacity to steer or maneuver a wheelchair without some type of power assistance. While this product is specifically targeted to the outdoor market, its design is adaptable for indoor use as well. It is substantially equivalent to several power chairs currently on the market as described later in this application. It is…
Read the full statement (139 words)
The Electric Mobility RASCAL Power Wheelchair is intended to serve the needs of individuals who have very limited mobility and a reduced capacity to steer or maneuver a wheelchair without some type of power assistance. While this product is specifically targeted to the outdoor market, its design is adaptable for indoor use as well. It is substantially equivalent to several power chairs currently on the market as described later in this application. It is extremely stable and durable and it is designed to carry up to 250 pounds on our standard unit and 400 pounds on our heavy duty unit. It is capable of operating over smooth indoor surfaces, or moderately rough, moderately soft, and uneven outdoor surfaces. It is capable of negotiating small obstacles and curbs and its spring suspension provides for a smooth ride and easier handling.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972370: Rascal Power Chair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972370
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026