Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistRoyalVibe Health Ltd. was warned for manufacturing and distributing multiple medical devices—including the CellQuicken Analyzer, RoyalVibe Ultrasound Generator, Envirovibe Water Restructuring Pad, Brainvibe Neuroplasticity Visual Program, RoyalVibe Therapy Balls, and companion software—without required premarket approval (PMA) applications, rendering the products adulterated under federal law. During an inspection in June-July 2022, the FDA found that the company had failed to obtain PMA clearance despite marketing devices intended for diagnosis, treatment, or mitigation of disease or affecting body function. Although the company agreed to cease U.S. sales, the FDA identified ongoing violations including active product websites still offering purchases and a mobile application available for download as of the warning letter date. The company was directed to submit a remediation plan addressing previously distributed devices and detailing steps taken to remove products from the U.S. market.