iBOT Personal Mobility Device (iBOT PMD)
FDA 510(k) clearance K210920 · decided 2021-06-16
Clearance details
- K-number
- K210920
- Device name
- iBOT Personal Mobility Device (iBOT PMD)
- Applicant
- Mobius Mobility
- Decision
- Substantially Equivalent
- Date received
- 2021-03-29
- Decision date
- 2021-06-16
- Days to decision
- 79 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
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| iBOT® PMD (K243442) | Mobius Mobility | 2025-01-30 |
| Next Generation iBOT (K172601) | Deka Research & Development Corp. | 2018-03-02 |
Recalls involving this device
No recalls on record reference this clearance.