Kappler USA
Country not established
- Devices
- 2
What Kappler USA makes
Kappler USA manufactures the COOL-ZONE, a device designed for thermal management, and the MED-GUARD SURGEON'S GOWN, a protective garment for medical personnel.
These products are classified as Class II devices under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
Cool-Zone Ref K963809
Regimes: 510(k) Registry: 510(k)Med-Guard Surgeon's Gown Ref K992445
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Kappler USA have in the registry?
The registry currently lists 2 devices for Kappler USA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kappler USA's devices?
Among its 2 most recently registered devices, Kappler USA has devices listed in FDA 510(k) (2 devices).
What risk classes do Kappler USA's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Kappler USA's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kappler USA in the registry?
The most recently registered devices listed for Kappler USA include COOL-ZONE and MED-GUARD SURGEON'S GOWN.