Inova Labs, Inc.
United StatesFDA applicant, unverified
- Devices
- 13
What Inova Labs, Inc. makes
Inova Labs, Inc. manufactures portable oxygen concentrators, including the LIFECHOICE OXYGEN CONCENTRATOR and the ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM, designed for home and travel use. The company also produces the Aria System, a device intended for continuous oxygen therapy delivery. These products are intended to filter ambient air to provide concentrated oxygen for patients with respiratory conditions.
The company’s devices fall under FDA Class II regulation and are listed via the 510(k) pathway in the United States. The portfolio is authorised for commercial distribution in the US market under these regulatory frameworks.
Catalogue
Search and filter all 13 devicesCompany details
- DUNS number
- 016523183
- [email protected]
- Phone
- (866) 647 0691
Frequently asked questions
How many devices does Inova Labs, Inc. have in the registry?
The registry currently lists 13 devices for Inova Labs, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Inova Labs, Inc.'s devices?
Among its 13 most recently registered devices, Inova Labs, Inc. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (10 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Inova Labs, Inc.'s devices fall under?
Among its 13 most recently registered devices, the classes recorded for Inova Labs, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Inova Labs, Inc. in the registry?
The most recently registered devices listed for Inova Labs, Inc. include Aria Free™ R0003, Aria Free™ R0004, Aria Free™ R0002 and Aria Free™ R0005.