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Thermoteknix System Limited was cited for manufacturing and marketing the FevIR Scan 2, a thermal imaging device for measuring body temperature, as an unapproved medical device intended to mitigate, prevent, treat, diagnose, or cure COVID-19. The company violated FDA regulations by making disease claims on its website and social media platforms—including statements that the product was "specially engineered to help fight the spread of coronavirus" and assist with pandemic safety measures—without obtaining required FDA clearance or approval. These marketing claims transformed the device from a general-purpose temperature measurement tool into a regulated medical device under the Federal Food, Drug, and Cosmetic Act, rendering the product both adulterated and misbranded.