Omni Therm, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Omni Therm, Inc. makes
Omni Therm, Inc. manufactures disposable temperature monitoring devices and reusable thermal therapy packs, including single-use temperature monitors, hot packs, cold gel packs, and warm gel packs for medical and clinical applications.
Their products are regulated under FDA 510(k) clearance as Class I and Class II devices, with listings in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Omni Therm Temperature Monitor Ref K864853
Regimes: 510(k) Registry: 510(k)Imni Hot Packs Ref K955788
Regimes: 510(k) Registry: 510(k)Omni Cold Gel Packs Ref K961176
Regimes: 510(k) Registry: 510(k)Omni Warm Gel Packs Ref K936084
Regimes: 510(k) Registry: 510(k)Omni Cold Gel Packs Ref K954877
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Omni Therm, Inc. have in the registry?
The registry currently lists 5 devices for Omni Therm, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omni Therm, Inc.'s devices?
Among its 5 most recently registered devices, Omni Therm, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Omni Therm, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Omni Therm, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Omni Therm, Inc. in the registry?
The most recently registered devices listed for Omni Therm, Inc. include OMNI THERM TEMPERATURE MONITOR, IMNI HOT PACKS, OMNI COLD GEL PACKS and OMNI WARM GEL PACKS.