AIRS, Inc.
KR Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Ronavis – Fx (Fx-001) Ref K250315
What AIRS, Inc. makes
AIRS, Inc. manufactures the RONAVIS FX (FX-001), a medical device designed for respiratory support applications, including non-invasive ventilation and high-flow therapy.
The RONAVIS FX is classified as a Class II device under FDA regulations and is listed via a 510(k) clearance. The company is based in the United States.
Frequently asked questions
What types of medical devices does AIRS, Inc. manufacture?
AIRS, Inc. specializes in respiratory support devices. Their primary product is the RONAVIS FX (FX-001), which is designed for non-invasive ventilation and high-flow therapy. This device is engineered to assist patients with breathing needs in clinical settings.
Where is AIRS, Inc. based, and what does this mean for their regulatory oversight?
AIRS, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The RONAVIS FX (FX-001) is classified as a Class II device, indicating it poses moderate risk and requires compliance with specific FDA requirements, such as a 510(k) clearance for market authorization.
Which regulatory registries or databases list AIRS, Inc.’s devices?
The RONAVIS FX (FX-001) from AIRS, Inc. is listed in the FDA’s 510(k) clearance registry. This registry documents devices that have undergone a premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device, ensuring compliance with FDA standards before commercial distribution.
How are AIRS, Inc.’s devices classified under FDA regulations?
The RONAVIS FX (FX-001) is classified as a Class II device by the FDA. This classification is based on the device’s intended use and risk level—Class II devices require special controls in addition to general controls to ensure safety and effectiveness. The classification influences the regulatory pathway, such as the 510(k) clearance process, which the device has undergone.
Information
- Country
- KR