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”.
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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.
It can be used as a second-line treatment in an emergency when initial basic life support (BLS) choking protocols have not been successful.
LifeVac is approved for use as a single-use, non-powered, non-invasive airway clearance device.
It is designed for both adult and paediatric individuals aged one year and above and can be operated by either lay persons or medical professionals who are at least 18 years old. Potential settings for use include nursing homes, homes, schools and restaurants.
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By GlobalDataThe FDA has determined that Class II classification, combined with general and special controls, provides reasonable assurance regarding the effectiveness and safety of the device in its intended application.
LifeVac founder and CEO Arthur Lih said: “As stated in the order, LifeVac is intended to be used after a BLS choking protocol fails. This classification creates a clear regulatory framework for suction anti-choking devices used as a second-line treatment.”
As per the order, LifeVac may immediately market its suction anti-choking device in accordance with the De Novo request and must adhere to all outlined general and special controls set by the FDA.
LifeVac is registered with regulatory agencies, including the Australian Register of Therapeutic Goods (ARTG), and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
