Rehabilitation Institute, Loma Linda University Med
Country not established
- Devices
- 1
What Rehabilitation Institute, Loma Linda University Med makes
The Rehabilitation Institute at Loma Linda University Medical Center designs and provides cranial remolding helmets, which are custom-fitted devices used to correct skull deformities in infants.
The cranial remolding helmet is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The institute operates within the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Rehabilitation Institute, Loma Linda University Med have in the registry?
The registry currently lists 1 device for Rehabilitation Institute, Loma Linda University Med. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rehabilitation Institute, Loma Linda University Med's devices?
Among its 1 most recently registered device, Rehabilitation Institute, Loma Linda University Med has devices listed in FDA 510(k) (1 device).
What risk classes do Rehabilitation Institute, Loma Linda University Med's devices fall under?
Among its 1 most recently registered device, the classes recorded for Rehabilitation Institute, Loma Linda University Med's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Rehabilitation Institute, Loma Linda University Med in the registry?
The most recently registered devices listed for Rehabilitation Institute, Loma Linda University Med include LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET.