Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistLifeVac, LLC was warned for marketing the LifeVac Rescue Suction Device, a Class III airway clearance device, without FDA authorization in violation of the Federal Food, Drug, and Cosmetic Act. The device was found to be adulterated because the company failed to obtain either an approved Premarket Approval (PMA) application or an Investigational Device Exemption (IDE) before marketing the product. Despite FDA notifications in April and May 2023 regarding the correct device classification and subsequent cease-and-desist orders issued in June and August 2025, the company continued to distribute the unauthorized device.