Oxyheal Medical Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Oxyheal Medical Systems, Inc. makes
Oxyheal Medical Systems, Inc. manufactures multiplace hyperbaric chamber systems designed for medical oxygen therapy, including models with touchscreen control interfaces. These systems are intended for use in clinical settings to treat conditions such as decompression sickness, wound healing, and other indications requiring hyperbaric oxygen therapy.
The company’s products are classified as Class II devices under FDA regulations and are supported by 510(k) clearances. These systems are listed in the FDA’s regulatory database, and the manufacturer operates from the United States.
Catalogue
Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System Ref K152223
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Oxyheal Medical Systems, Inc. have in the registry?
The registry currently lists 2 devices for Oxyheal Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oxyheal Medical Systems, Inc.'s devices?
Among its 2 most recently registered devices, Oxyheal Medical Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Oxyheal Medical Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Oxyheal Medical Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Oxyheal Medical Systems, Inc. in the registry?
The most recently registered devices listed for Oxyheal Medical Systems, Inc. include Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System and OxyHeal 4000 Multiplace Hyperbaric Chamber Family.