Commwell, Ltd.
Country not established
- Devices
- 3
What Commwell, Ltd. makes
Commwell, Ltd. manufactures wearable physiological monitoring devices, including the Physioglove ES with integrated ECG analysis and standalone versions for vital sign tracking. These devices are designed for continuous monitoring of heart rate and other physiological metrics, often used in clinical and research settings.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. These devices are registered in the U.S. and comply with applicable FDA requirements for medical device authorisation.
Catalogue
Physioglove Es With Ecg Analysis Ref K103791
Regimes: 510(k) Registry: 510(k)Physioglove Es Ref K050674
Regimes: 510(k) Registry: 510(k)Physioglove For Use With Physioglove ES1 Ref K083677
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Commwell, Ltd. have in the registry?
The registry currently lists 3 devices for Commwell, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Commwell, Ltd.'s devices?
Among its 3 most recently registered devices, Commwell, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Commwell, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Commwell, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Commwell, Ltd. in the registry?
The most recently registered devices listed for Commwell, Ltd. include PHYSIOGLOVE ES WITH ECG ANALYSIS, PHYSIOGLOVE ES and PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1.