Novaplex, Inc.
Country not established
- Devices
- 1
What Novaplex, Inc. makes
Novaplex, Inc. manufactures the MAGIC EAR, ELAIN, a Class I medical device designed for hearing enhancement or auditory stimulation.
The company’s portfolio is regulated under the FDA’s 510(k) clearance process and is listed in the United States.
Catalogue
Magic Ear, Elain Ref K942107
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Novaplex, Inc. have in the registry?
The registry currently lists 1 device for Novaplex, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Novaplex, Inc.'s devices?
Among its 1 most recently registered device, Novaplex, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Novaplex, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Novaplex, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Novaplex, Inc. in the registry?
The most recently registered devices listed for Novaplex, Inc. include MAGIC EAR, ELAIN.