Ultravoice, Ltd.
Country not established
- Devices
- 1
What Ultravoice, Ltd. makes
Ultravoice, Ltd. manufactures an American artificial larynx, a device designed to restore speech function for individuals with vocal cord paralysis or laryngectomy.
The company’s portfolio is regulated under FDA’s Class I device classification, with the artificial larynx authorised via the 510(k) pathway. The device is listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
American Artificial Larynx Ref K914816
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ultravoice, Ltd. have in the registry?
The registry currently lists 1 device for Ultravoice, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ultravoice, Ltd.'s devices?
Among its 1 most recently registered device, Ultravoice, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Ultravoice, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Ultravoice, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Ultravoice, Ltd. in the registry?
The most recently registered devices listed for Ultravoice, Ltd. include AMERICAN ARTIFICIAL LARYNX.