Hyperbaric Aerobics, Ltd.
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- Devices
- 1
What Hyperbaric Aerobics, Ltd. makes
Hyperbaric Aerobics, Ltd. manufactures the GAMOW hyperbaric bag, a portable device designed for hyperbaric oxygen therapy (HBOT) in controlled environments. The bag creates a pressurized chamber to deliver oxygen at elevated pressures, intended for medical applications such as wound healing, decompression sickness treatment, and carbon monoxide poisoning management.
The GAMOW hyperbaric bag is classified as a Class II medical device under US regulations and is subject to 510(k) clearance through the FDA. The company is based in the United States.
Catalogue
Gamow Hyperbaric Bag Ref K874752
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hyperbaric Aerobics, Ltd. have in the registry?
The registry currently lists 1 device for Hyperbaric Aerobics, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hyperbaric Aerobics, Ltd.'s devices?
Among its 1 most recently registered device, Hyperbaric Aerobics, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Hyperbaric Aerobics, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Hyperbaric Aerobics, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hyperbaric Aerobics, Ltd. in the registry?
The most recently registered devices listed for Hyperbaric Aerobics, Ltd. include GAMOW HYPERBARIC BAG.