11 Health and Technologies, LLC
FDA registration: United States Last updated 23 May 2026
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Ostom-I Alert Ref K140938
What 11 Health and Technologies, LLC makes
11 Health and Technologies, LLC manufactures the OSTOM-I ALERT, a device designed to monitor and alert for complications in ostomy patients by detecting changes in stoma condition or output.
The OSTOM-I ALERT is classified as a Class I medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Frequently asked questions
How many devices does 11 Health and Technologies, LLC have in the registry?
The registry currently lists 1 device for 11 Health and Technologies, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list 11 Health and Technologies, LLC's devices?
Among its 1 most recently registered device, 11 Health and Technologies, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do 11 Health and Technologies, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for 11 Health and Technologies, LLC's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from 11 Health and Technologies, LLC in the registry?
The most recently registered devices listed for 11 Health and Technologies, LLC include OSTOM-I ALERT.
Information
- FDA registration
- United States