510(k) · Cleared
Recalled · Class II · 2025iBOT® PMD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mobius Mobility · IMK Wheelchair, Stair Climbing
Cleared on Jan 30, 2025 as substantially equivalent to K210920 (Mobius Mobility, 2021) after an 85-day review. Its family tree reaches back 3 generations to 2005. It has been recalled once.
- Decided
- Jan 30, 2025
- Review
- 85 days
- Class
- Class II
- Product code
- IMK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to P020033/
- Root · 3 generations backP020033/
S002 Independence Ibot 3000/4000 Mobility SystemIndependence Technology, LLC · 2005 - 2 generations backK172601 Next Generation iBOTDeka Research & Development Corp. · 2018
- 1 generation backK210920 iBOT Personal Mobility Device (iBOT PMD)Mobius Mobility · 2021
- This deviceK243442 iBOT® PMDMobius Mobility · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P020033/ | Independence Ibot 3000/4000 Mobility System | Independence Technology, LLC | 2005 | — |
| −2 | K172601 | Next Generation iBOT | Deka Research & Development Corp. | 2018 | — |
| −1 | K210920 | iBOT Personal Mobility Device (iBOT PMD) | Mobius Mobility | 2021 | — |
| 0 (this device) | K243442 | iBOT® PMD | Mobius Mobility | 2025 | — |
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 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 K210920 iBOT Personal Mobility Device (iBOT PMD)score 4.8 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K210920 | iBOT Personal Mobility Device (iBOT PMD)Summary page 5…Physical Medicine Predicate Device(s) The iBOT® PMD is substantially equivalent to the iBOT® Personal Mobility Device (“iBOT PMD”), which was previously cleared under K210920. K243442 - 510(k) Summary Device Description The proposed device is an update to the previously cleared iBOT®… | 2021 |
| † | K150574 | Modular Power Positioning System | 2015 |
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 24, 2025 | Class II | Z-1965-2025 | Software design | Software issue that could potentially lead to the device tipping over from Balance Mode. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All IMK devicesIMK Wheelchair, Stair Climbing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The iBOT® Personal Mobility Device ("iBOT® PMD") is intended to provide indoor and outdoor mobility to persons restricted to a sitting position. The device allows for the option to climb stairs. The operator(s), either the wheelchair occupant or an assistant, must meet the requirements of the training certification program. The wheelchair occupant must meet the requirements of the user assessment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243442: iBOT® PMD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243442
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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