LifeVac has received De Novo classification from the US Food and Drug Administration (FDA) for its suction anti-choking device under 21 Code of Federal Regulations (CFR) 874.5400.

The authorisation establishes the device type “suction anti-choking device as a second-line treatment”.

Under this order, the FDA classifies LifeVac as a Class II medical device. It is defined as the one intended to resolve choking in victims with complete airway obstruction through the application of suction.