510(k) · Cleared
ClearediBOT Personal Mobility Device (iBOT 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 Jun 16, 2021 as substantially equivalent to K172601 (Deka Research & Development Corp., 2018) after a 79-day review. Its family tree reaches back 2 generations to 2005. 1 later device descends from it.
- Decided
- Jun 16, 2021
- Review
- 79 days
- Class
- Class II
- Product code
- IMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P020033/
- Root · 2 generations backP020033/
S002 Independence Ibot 3000/4000 Mobility SystemIndependence Technology, LLC · 2005 - 1 generation backK172601 Next Generation iBOTDeka Research & Development Corp. · 2018
- This deviceK210920 iBOT Personal Mobility Device (iBOT PMD)Mobius Mobility · 2021
- Descendant · cites it directly · 0 of its ownK243442 iBOT® PMDMobius Mobility · 2025 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K243442iBOT® PMDMobius Mobility · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P020033/ | Independence Ibot 3000/4000 Mobility System | Independence Technology, LLC | 2005 | — |
| −1 | K172601 | Next Generation iBOT | Deka Research & Development Corp. | 2018 | — |
| 0 (this device) | K210920 | iBOT Personal Mobility Device (iBOT PMD) | Mobius Mobility | 2021 | — |
| +1 | K243442 | iBOT® PMD | Mobius Mobility | 2025 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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 K243442 iBOT® PMDscore 7.4 · 3 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 |
|---|---|---|---|
| * | K172601 | Next Generation iBOTSummary page 4…Physical Medicine Predicate Device(s) The iBOT® PMD is substantially equivalent to the Next Generation iBOT®, which was previously cleared under 510(k) #K172601. 510(k) Summary, K210920 Reference Device Permobil F5 Corpus VS (K191874). Device Description The proposed d… | 2018 |
| † | K191874 | F5 Corpus VS | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243442 | iBOT® PMD | 2025 | 0 |
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 13.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K243442 (Mobius Mobility, 2025) has gone furthest, with 0 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. 2021, 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 who meet the requirements of the user assessment and training certification program. The device allows for the option to climb stairs. Companions who are required to provide assistance during Assisted Stair Climbing Mode must meet the requirements of the training certification program. The iBOT® Personal Mobility Device ("iBOT® PMD") Occupied Transport option is indicated for providing persons, unable to transfer from their wheelchair into a standard factory motor vehicle seat, the option for transportation while seated in their iBOT® PMD wheelchair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210920 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210920: iBOT Personal Mobility Device (iBOT PMD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210920
Report an extraction error
Are you the manufacturer?
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