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SeniorLife Technologies, Inc. was cited for distributing SeniorLife.AI, a mobile application classified as a medical device intended for disease diagnosis or treatment, without required premarket approval (PMA) or an investigational device exemption (IDE). The company failed to submit a 510(k) notification to the FDA before commercializing the device and incorrectly registered it under a measuring exercise equipment classification that did not match its actual intended use. The device was found to be adulterated and misbranded in violation of the Federal Food, Drug, and Cosmetic Act, with an FDA inspection conducted at the firm's Bellevue, Washington facility from March 24–26, 2025.