02 Marketing Group, Inc.
US Last updated 23 May 2026
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Home/Commercial Oxygen Unit By System O2 Ref K991569
What 02 Marketing Group, Inc. makes
The company manufactures home and commercial oxygen units, including the System O₂ line, designed for medical oxygen delivery in residential or non-clinical settings.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Frequently asked questions
What types of medical devices does 02 Marketing Group, Inc. manufacture?
02 Marketing Group, Inc. specializes in home and commercial oxygen units, such as the System O₂ line. These devices are intended for delivering medical oxygen in residential or non-clinical environments, ensuring patients or users can access oxygen therapy outside of hospital settings.
Where is 02 Marketing Group, Inc. based?
The company is headquartered in the United States. This location allows it to comply with U.S. regulatory standards and distribute its devices domestically and potentially internationally, depending on market needs.
How are the devices manufactured by 02 Marketing Group, Inc. classified under FDA regulations?
The devices produced by 02 Marketing Group, Inc., such as the System O₂ line, fall under Class II classification according to FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls—like performance standards or post-market surveillance—to ensure safety and effectiveness.
Which regulatory registries or databases list the devices made by 02 Marketing Group, Inc.?
The company’s devices, including the System O₂ line, are listed via FDA 510(k) clearance, which is a premarket submission required for Class II devices to demonstrate substantial equivalence to a legally marketed predicate device. This clearance ensures the devices meet FDA requirements before entering the market.
Information
- Country
- US