Gema, Inc.
Country not established
- Devices
- 1
What Gema, Inc. makes
Gema, Inc. produces the BALLERT CRANIAL MOLDING HELMET, which is a Class II medical device designed to help correct skull deformities in infants.
The company is based in the US, and its products are listed in the FDA 510(k) registry, indicating they have been cleared for marketing through the premarket notification process.
Catalogue
Ballert Cranial Molding Helmet Ref K011433
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gema, Inc. have in the registry?
The registry currently lists 1 device for Gema, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gema, Inc.'s devices?
Among its 1 most recently registered device, Gema, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Gema, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Gema, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gema, Inc. in the registry?
The most recently registered devices listed for Gema, Inc. include BALLERT CRANIAL MOLDING HELMET.