Hyperbaric America, LLC
Country not established
- Devices
- 1
What Hyperbaric America, LLC makes
Hyperbaric America, LLC manufactures monoplace hyperbaric chamber systems designed for medical oxygen therapy under increased atmospheric pressure. These systems are intended for clinical use in treating conditions such as decompression sickness, carbon monoxide poisoning, and wound healing.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) clearance process. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hyperbaric America, LLC have in the registry?
The registry currently lists 1 device for Hyperbaric America, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hyperbaric America, LLC's devices?
Among its 1 most recently registered device, Hyperbaric America, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Hyperbaric America, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Hyperbaric America, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hyperbaric America, LLC in the registry?
The most recently registered devices listed for Hyperbaric America, LLC include HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS.