LifeVac Travel Kit | Choking Rescue Device

LifeVac is the first and only FDA-authorized suction anti-choking device as a second-line treatment. The Travel Kit provides customers with both an adult and pediatric mask. Designed for easy access on the go, the Travel Kit comes in a zip-up yellow bag—perfect for keeping in your home, office, car, luggage, or diaper bag. Free online training is available.

KIT INCLUDES

• LifeVac unit
• 1 adult mask
• 1 pediatric mask
• Instructions for use
• Packaged in a yellow zippered travel bag

PRODUCT & SAFETY INFORMATION

FDA De Novo Classification

LifeVac received FDA authorization through the De Novo classification pathway, which establishes a new regulatory classification for certain novel medical devices that do not have an existing legally marketed predicate device.

Through this process, the FDA established a new device category for suction-based anti-choking devices intended for use as a second-line treatment.

Regulatory Requirements

LifeVac is authorized for commercial sale in the United States under this regulatory classification. Manufacturers seeking to market similar devices may be required to pursue FDA clearance through the 510(k) pathway and demonstrate compliance with applicable regulatory requirements and special controls for this device category.

Official FDA Documentation

For reference and transparency, the following FDA documents are included with this product information:

• FDA De Novo Status
• FDA Close-Out Letter
• FDA Communication Update

These documents provide supporting information regarding the regulatory determination and classification issued by the U.S. Food and Drug Administration.