Data / Medical devices / United States / Mobius Mobility LLC
Mobius Mobility LLC: FDA-registered device maker in Manchester, NH, United States, 3 510(k) clearances
Mobius Mobility LLC is registered with the FDA (registration 3014522447) in Manchester, NH, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 30, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014522447
- Address
- 540 North Commercial St. Suite 310, Manchester, NH, United States, 03101
- Owner or operator
- Mobius Mobility LLC (10057767)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export
- First device listed
- May 23, 2018
- Registered through
- 2026
- Brand names listed
- iBOT PMD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Wheelchair, Powered | ITI | 2 | Complaint file establishment, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Wheelchair, Stair Climbing | IMK | 2 | Complaint file establishment, Manufacturer, Manufacturer for export | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 30, 2025 | K243442 | iBOT® PMD | IMK | Substantially Equivalent | Mobius Mobility | accessdata.fda.gov |
| June 16, 2021 | K210920 | iBOT Personal Mobility Device (iBOT PMD) | IMK | Substantially Equivalent | Mobius Mobility | accessdata.fda.gov |
| March 2, 2018 | K172601 | Next Generation iBOT | IMK | Substantially Equivalent | Deka Research & Development Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 24, 2025 | 96834 | Class II | Ongoing | 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. | accessdata.fda.gov |
Compare with other makers
Updated June 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.