Wello, Inc.
Country not established
- Devices
- 2
What Wello, Inc. makes
Wello, Inc. manufactures body temperature screening thermometer stations designed for use in public health settings, such as schools, workplaces, and healthcare facilities. These devices are intended to measure and monitor body temperature to help identify potential fever cases, supporting screening protocols for infectious disease control.
The company’s products are regulated as Class II medical devices in the U.S. and are listed under FDA’s 510(k) and UDI (Unique Device Identification) systems. The portfolio is authorised for commercial distribution in the United States.
Catalogue
- Registry: GUDID
welloStationX Ref K180298
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 117825202
Frequently asked questions
How many devices does Wello, Inc. have in the registry?
The registry currently lists 2 devices for Wello, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wello, Inc.'s devices?
Among its 2 most recently registered devices, Wello, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Wello, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Wello, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Wello, Inc. in the registry?
The most recently registered devices listed for Wello, Inc. include Wello, Inc welloStationX and welloStationX.