Hypersound Health, Inc.
Country not established
- Devices
- 1
What Hypersound Health, Inc. makes
Hypersound Health, Inc. manufactures the Hypersound Audio System (HSS), a medical device designed for focused ultrasound-based therapeutic applications, including non-invasive procedures for tissue ablation or stimulation.
The Hypersound Audio System is classified as a Class II device under FDA regulations and is authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Hypersound Audio System (Hss) Ref K133352
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hypersound Health, Inc. have in the registry?
The registry currently lists 1 device for Hypersound Health, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hypersound Health, Inc.'s devices?
Among its 1 most recently registered device, Hypersound Health, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Hypersound Health, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Hypersound Health, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hypersound Health, Inc. in the registry?
The most recently registered devices listed for Hypersound Health, Inc. include HYPERSOUND AUDIO SYSTEM (HSS).