FDA Product Code
FDA Product Code IMK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.3890
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243442 | iBOT® PMD | Mobius Mobility | 2025-01-30 | Traditional | PDF ↗ |
| K210920 | iBOT Personal Mobility Device (iBOT PMD) | Mobius Mobility | 2021-06-16 | Traditional | PDF ↗ |
| K172601 | Next Generation iBOT | Deka Research & Development Corp. | 2018-03-02 | Traditional | PDF ↗ |
Product code IMK · Class II · Physical Medicine. Data: openFDA.