K243442 is an FDA 510(k) clearance for the iBOT® PMD. This device is classified as a Wheelchair, Stair Climbing (Class II - Special Controls, product code IMK).
Submitted by Mobius Mobility (Manchester, US). The FDA issued a Cleared decision on January 30, 2025, 85 days after receiving the submission on November 6, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3890. 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..
| 510(k) Number | K243442 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2024 |
| Decision Date | January 30, 2025 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IMK - Wheelchair, Stair Climbing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3890 |
| 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. |