PMA · Approved
Recalled · 2010Independence (TM) Ibot 3000/4000 Mobility System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Independence Technology, LLC · IMK Wheelchair, Stair Climbing
Approved on Aug 13, 2003 through premarket approval, which rests on the device’s own clinical evidence after a 378-day review. It has been recalled 3 times.
- Decided
- Aug 13, 2003
- Review
- 378 days
- Class
- Class II
- Product code
- IMK
- Recalls
- 3
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P020033 has 2 supplements since 2004: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2004 | 1 |
| 2005 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IMK? 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 IMK device
- #1 K243442 iBOT® PMDscore 7.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
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 |
|---|---|---|---|---|
| Feb 22, 2010 | Not classified | Z-1775-2010 | Device Design | A thermal breaker in the battery pack has the potential to open due to overheating and disable one third of the cells in the affected battery pack. |
| Aug 30, 2004 | Not classified | Z-0022-05 | Other | Rocks and debris can enter into the wheel cluster housing through a damaged wheel cap causing wheel malfunction. |
| Jul 1, 2004 | Not classified | Z-1383-04 | Other | iBOT Mobility System may tip over due to malfunction in power base. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All IMK devicesIMK Wheelchair, Stair Climbing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IMK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IMK
Too few IMK 510(k)s in any year since 2007 to give a median.
Recalls per year · IMK
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMK
10in 2025
MAUDE reports naming product code IMK, 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 | 0 | — | 0 | 8 |
| 2008 | 0 | — | 0 | 12 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 0 | — | 1 | 5 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P020033 · printed Nov 6, 2026
Cite this page
510(k) Report. “P020033: Independence (TM) Ibot 3000/4000 Mobility System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P020033
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026