Clinical Research, Studies & Global Certifications | LifeVac™ Australia

Clinical Oversight & Regulatory Compliance

LifeVac™ is a non-invasive, suction-based airway clearance device registered as a medical tool across major global health authorities. Below is the technical summary of our independent testing and clinical safety profile.

Global Regulatory Registrations

The LifeVac™ technology is recognized and registered by the following health authorities as a Class I Medical Device:

  • [✓] TGA (Australia): Therapeutic Goods Administration Registered.
  • [✓] FDA (USA): Food and Drug Administration Registered.
  • [✓] MHRA (UK): Medicines and Healthcare products Regulatory Agency.
  • [✓] CE (Europe): European Conformity (EC) Registered.

Peer-Reviewed Medical Studies

LifeVac™ is the only suction-based airway clearance device with multiple independent, peer-reviewed publications confirming its efficacy and safety.

Study 1: Negative Pressure Efficacy

Independent testing published in the International Journal of Clinical Skills confirms that LifeVac creates over 300mmHg of suction—significantly higher than the pressure generated by standard chest compressions or abdominal thrusts.

Study 2: Success Rates in Geriatric Care

Clinical reports from long-term care facilities show a 99% success rate when LifeVac is used as a tertiary protocol for patients who are unable to receive the Heimlich maneuver due to physical disability or age.

Safety Engineering: The One-Way Valve

A primary concern in suction devices is the risk of pushing an obstruction deeper into the pharynx. The LifeVac™ utilizes a patented One-Way Valve System:

  • On the PUSH: The valve stays open to exhaust air out the sides, preventing air from entering the victim's lungs.
  • On the PULL: The valve closes, creating a complete vacuum seal that generates the negative pressure needed to dislodge the object.

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