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Adventure Innovations LLC was selling the Sani Bot D3, a medical device intended for cleaning CPAP sleep equipment, without obtaining required FDA marketing clearance or approval. The company violated federal law by distributing the device without a Premarket Approval (PMA) application or Investigational Device Exemption (IDE) in effect, and failed to submit a premarket notification (510(k)) before introducing the product into interstate commerce through Amazon. The device was determined to be both adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act for lacking the necessary regulatory authorizations prior to commercial distribution.