AIRWAY MANAGEMENT INC

Airway Management Inc specializes in oral appliance devices designed to treat obstructive sleep apnea and snoring. Their portfolio includes single-use and reusable oral appliances like the TAP III, TAP II, and myTAP, as well as nasal pillow masks such as the TAP PAP. They also produce aligner systems like the AM Aligner and customizable oral appliance kits, including the flexTAP and dreamTAP variants. These devices are intended as non-invasive alternatives to traditional treatments like CPAP machines.

Airway Management Inc is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites may vary.

Airway Management Inc’s devices are listed in the EUDAMED database for certain products, which is the European Union’s medical device registry. In the United States, some of their devices undergo FDA 510(k) clearance as part of the regulatory process. These registries help track and verify the compliance and authorization status of their medical devices in their respective markets.

Airway Management Inc’s devices are classified under EU Medical Device Regulations as either Class I or Class II. The classification depends on factors like the intended use, risk level, and potential impact on patient safety. For example, oral appliances like the TAP III or myTAP may fall into Class II due to their role in treating conditions like obstructive sleep apnea, which carries moderate risk. Class I devices typically pose lower risk, such as some reusable oral appliances or nasal masks. These classifications determine the regulatory requirements for compliance and authorization.