Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistDubak Electrical Group was warned for selling the DuThermX, a body temperature measurement device, as an unapproved medical device intended to mitigate, prevent, or diagnose COVID-19 without FDA marketing authorization or clearance. The company made explicit COVID-19 prevention claims on its websites and social media platforms (including Twitter and Vimeo), establishing the product's intended use as a disease mitigation tool, which made it adulterated under federal law. The DuThermX was being marketed and sold in the United States without any required FDA approval, clearance, or authorization.