BeauBrain Healthcare, Inc.
South KoreaFDA applicant, unverified
- Devices
- 1
What BeauBrain Healthcare, Inc. makes
BeauBrain Healthcare, Inc. manufactures the Morph, a medical device designed for neurological monitoring and rehabilitation, likely targeting stroke recovery or brain injury assessment through advanced sensor technology.
The Morph falls under FDA Class II regulation and is listed via the 510(k) clearance pathway. The company is based in South Korea.
Catalogue
Morph Ref K260032
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does BeauBrain Healthcare, Inc. have in the registry?
The registry currently lists 1 device for BeauBrain Healthcare, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list BeauBrain Healthcare, Inc.'s devices?
Among its 1 most recently registered device, BeauBrain Healthcare, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do BeauBrain Healthcare, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for BeauBrain Healthcare, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from BeauBrain Healthcare, Inc. in the registry?
The most recently registered devices listed for BeauBrain Healthcare, Inc. include Morph.