Munevo Inc.
Country not established
Part of munevo GmbH
Munevo Inc. is a medical device manufacturer, with 1 device listed in FDA GUDID (FDA Class I) and 1 FDA recall as of 15 Nov 2026.
- Devices
- 1
- FDA recalls
- 11 ongoing
Registry facts
- Registries
- FDA GUDID 1
- Device classes
- FDA Class I 1
- FDA recalls
- Sites and related companies
- Identifiers
- DUNS 118704707
At a glance
Market reach
- United States
- FDA recalls
What Munevo Inc. makes
Munevo Inc. manufactures wheelchair steering and control units, including the munevo DRIVE, designed to enhance mobility and user independence for wheelchair users.
The company’s products are classified as Class I medical devices and are listed in the FDA’s Unique Device Identifier (UDI) database, adhering to U.S. regulatory requirements.
Catalogue
- Registry: GUDID
Company details
- DUNS number
- 118704707
FDA recalls
FDA recall records list 1 recall initiated by Munevo Inc., initiated on 2026-06-19. By recorded status: 1 ongoing. The reasons filed fall into these groups: software or firmware and performance or accuracy. 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 0
- 2026 1
2026
- 19 Jun 2026 Z-2856-2026 Class II Ongoing A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift or imprecise control while driving the wheelchair. The wheelchair may veer from its intended path, which may cause in low-speed collision, tipping, or injuries to user or bystanders.
Full distribution text
- 19 Jun 2026 Z-2856-2026 Class II Ongoing A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift or imprecise control while driving the wheelchair. The wheelchair may veer from its intended path, which may cause in low-speed collision, tipping, or injuries to user or bystanders.
Frequently asked questions
How many devices does Munevo Inc. have in the registry?
The registry currently lists 1 device for Munevo Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Munevo Inc.'s devices?
Among its 1 most recently registered device, Munevo Inc. has devices listed in FDA GUDID (1 device).
What risk classes do Munevo Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Munevo Inc.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Munevo Inc.?
FDA recall records list 1 recall initiated by Munevo Inc., the most recent initiated on 19 Jun 2026. 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 Munevo Inc. in the registry?
The most recently registered devices listed for Munevo Inc. include munevo DRIVE V2.