iBOT® PMD
FDA 510(k) clearance K243442 · decided 2025-01-30
Clearance details
- K-number
- K243442
- Device name
- iBOT® PMD
- Applicant
- Mobius Mobility
- Decision
- Substantially Equivalent
- Date received
- 2024-11-06
- Decision date
- 2025-01-30
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- IMK
- Device class
- 2
- Regulation number
- 890.3890
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Manchester, NH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mobius Mobility
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| iBOT Personal Mobility Device (iBOT PMD) (K210920) | Mobius Mobility | 2021-06-16 |
| Next Generation iBOT (K172601) | Deka Research & Development Corp. | 2018-03-02 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| iBOT PMD with software version 01.05.24. Personal Mobility Device. recall (Z-1965-2025) | Mobius Mobility LLC | 2025-06-12 |