Manchester, NH, US · 2 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| IMK | — | — | — | 2 | 2025-01-30 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-04-24 | Class II | Ongoing | Z-1965-2025 | iBOT PMD with software version 01.05.24. Personal Mobility Device. | — | Software issue that could potentially lead to the device tipping over from Balance Mode. |