USA Therm, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What USA Therm, Inc. makes
Usa Therm, Inc. manufactures thermovisual cameras designed for thermal imaging applications, including non-contact temperature monitoring and thermal pattern analysis. These devices are primarily used in industrial, medical, and research settings to detect temperature variations and assess thermal properties of surfaces or objects.
The company’s thermovisual cameras are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are intended for use in the United States, where they must comply with applicable FDA requirements for thermal imaging systems.
Catalogue
- Registry: GUDID
ThermPix Thermovisual Camera Ref K213650
Regimes: 510(k) Registry: 510(k)ThermPix Thermovisual Camera Ref K232462
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 111441897
- [email protected]
- Phone
- (844) 998-4376
Frequently asked questions
How many devices does Usa Therm, Inc. have in the registry?
The registry currently lists 3 devices for Usa Therm, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Usa Therm, Inc.'s devices?
Among its 3 most recently registered devices, Usa Therm, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Usa Therm, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Usa Therm, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Usa Therm, Inc. in the registry?
The most recently registered devices listed for Usa Therm, Inc. include ThermPix TPix-01 and ThermPix Thermovisual Camera.