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Kogniz, Inc. was warned for offering the KOGNIZ TC20, a telethermographic device for measuring human body temperature, for sale in the United States without required FDA marketing approval, clearance, or authorization. The product violated the Federal Food, Drug, and Cosmetic Act by lacking an approved premarket approval (PMA) application or investigational device exemption (IDE), making it adulterated, and by failing to submit a 510(k) notification before introducing it into interstate commerce, rendering it misbranded. The FDA identified that such telethermographic devices present potentially serious public health risks, including the possibility of incorrectly detecting normal body temperature.