Mobius Mobility
United Statesfrom the FDA registration address FDA FEI 3014522447
Mobius Mobility is a medical device manufacturer, with 4 devices listed in FDA 510(k) and FDA GUDID (FDA Class II) and 1 FDA recall as of 15 Nov 2026.
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 11 ongoing
Registry facts
- Registries
- FDA 510(k) 2
- FDA GUDID 2
- Device classes
- FDA Class II 4
- FDA recalls
- Identifiers
- FDA FEI 3014522447
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Mobius Mobility makes
Mobius Mobility manufactures electric-motor-driven wheelchairs with occupant-controlled operation, powered steering, and non-collapsible frames. These devices include models like the iBOT and iBOT PMD, designed for personal mobility.
The company’s products are regulated as Class II medical devices in the US, with records supported by FDA 510(k) clearances and FDA Unique Device Identifiers (UDI). The portfolio is listed under these regulatory pathways.
Catalogue
- Regimes: 510(k) Registry: GUDID
- Registry: GUDID
iBOT® PMD Ref K243442
Regimes: 510(k) Registry: 510(k)iBOT Personal Mobility Device (iBOT PMD) Ref K210920
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3014522447
- Address
- 540 North Commercial St., Manchester, NH, 03101
FDA recalls
FDA recall records list 1 recall initiated by Mobius Mobility, initiated on 2025-04-24. By recorded status: 1 ongoing. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 24 Apr 2025 Z-1965-2025 Class II Ongoing Software issue that could potentially lead to the device tipping over from Balance Mode.
Frequently asked questions
How many devices does Mobius Mobility have in the registry?
The registry currently lists 4 devices for Mobius Mobility. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mobius Mobility's devices?
Among its 4 most recently registered devices, Mobius Mobility has devices listed in FDA 510(k) (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Mobius Mobility's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Mobius Mobility's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Mobius Mobility?
FDA recall records list 1 recall initiated by Mobius Mobility, the most recent initiated on 24 Apr 2025. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Mobius Mobility in the registry?
The most recently registered devices listed for Mobius Mobility include iBOT iBOT PMD, iBOT(R) iBOT PMD, iBOT® PMD and iBOT Personal Mobility Device (iBOT PMD).