FDA product code IMK: Wheelchair, Stair Climbing
IMK is the FDA product code for wheelchair, stair climbing. It is a Class II device, regulated under 21 CFR 890.3890 and reviewed by the Physical Medicine panel. FDA has cleared 3 510(k) submissions under IMK, 1 in the last five years, from 2 different applicants. The average 510(k) review took 116 days (median 85); 85 days on average over the last three years. 2 PMA applications cite this product code. FDA has posted 4 recalls for IMK devices, 1 initiated in the last five years.
Definition
A device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility.
Classification
| Field | Value |
|---|---|
| Device name | Wheelchair, Stair Climbing |
| Device class | Class II |
| Regulation | 21 CFR 890.3890 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
510(k) clearances per year for IMK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 184 |
| 2021 | 1 | 79 |
| 2025 | 1 | 85 |
Compare with all 510(k) review times · Search every IMK clearance
Top IMK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mobius Mobility | 2 | 2025-01-30 |
| Deka Research & Development Corp. | 1 | 2018-03-02 |
Most recent IMK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243442 | Mobius Mobility | iBOT® PMD | 2025-01-30 | 85 |
| K210920 | Mobius Mobility | iBOT Personal Mobility Device (iBOT PMD) | 2021-06-16 | 79 |
| K172601 | Deka Research & Development Corp. | Next Generation iBOT | 2018-03-02 | 184 |
Recalls for IMK devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-04-24.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code IMK?
IMK is the FDA product code for wheelchair, stair climbing. It is a Class II device, regulated under 21 CFR 890.3890 and reviewed by the Physical Medicine panel.
What device class is IMK?
Class II, regulation 21 CFR 890.3890. Typical premarket route: 510(k).
How long does a 510(k) take for product code IMK?
Across 3 cleared submissions the average was 116 days from receipt to decision (median 85).
Which companies have the most IMK clearances?
Mobius Mobility (2); Deka Research & Development Corp. (1).
Have IMK devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2025-04-24.
Next steps
- Run an FDA pathway report with predicate devices for product code IMK
- Run a recall and safety report across every IMK manufacturer
- Watch product code IMK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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