PMA · Approved
ApprovedIndependence 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 Mar 15, 2005 through premarket approval, which rests on the device’s own clinical evidence after a 187-day review. 3 later devices descend from it.
- Decided
- Mar 15, 2005
- Review
- 187 days
- Class
- Class II
- Product code
- IMK
- Recalls
- None
3 later devices descend from it, 1 citing it directly.
- This deviceP020033/
S002 Independence Ibot 3000/4000 Mobility SystemIndependence Technology, LLC · 2005 - Descendant · cites it directly · 2 of its ownK172601 Next Generation iBOTDeka Research & Development Corp. · 2018
- Descendant · 2 generations on · 1 of its ownK210920 iBOT Personal Mobility Device (iBOT PMD)Mobius Mobility · 2021
- Descendant · 3 generations on · 0 of its ownK243442 iBOT® PMDMobius Mobility · 2025 · Recalled
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 |
|---|---|---|---|---|---|
| 0 (this device) | P020033/ | Independence Ibot 3000/4000 Mobility System | Independence Technology, LLC | 2005 | — |
| +1 | K172601 | Next Generation iBOT | Deka Research & Development Corp. | 2018 | — |
| +2 | K210920 | iBOT Personal Mobility Device (iBOT PMD) | Mobius Mobility | 2021 | — |
| +3 | K243442 | iBOT® PMD | Mobius Mobility | 2025 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172601 | Next Generation iBOT | 2018 | 2 |
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?
- Of its descendants, K172601 (Deka Research & Development Corp., 2018) has gone furthest, with 2 descendants of its own.
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/S002 · printed Nov 6, 2026
Cite this page
510(k) Report. “P020033/S002: Independence 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/S002
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026