The Food and Drug Administration (FDA) has issued a warning regarding the use of certain ultrasound devices that have been unlawfully sold to consumers for medical purposes. These devices are sold in kits and manufactured by RoyalVibe Health, CellQuicken, and Well-Being Reality. The kits include the Brainvibe Neuroplasticity Visual Program, the CellQuicken Analyzer (Smart-Watch and Software), the Envirovibe Water Restructuring Pad, the RoyalVibe Application, the RoyalVibe Therapy Balls, and the RoyalVibe Ultrasound Generator. The Companies have been marketing these unauthorized devices to diagnose and treat a variety of conditions including cancer, diabetes, heart disease, Parkinson Disease, and depression.
According to the FDA, none of these devices have been evaluated for safety or effectiveness and use by consumers may result in adverse events such as pain, bruising, burns, scarring, nerve damage, muscle weakness, or numbness. The Agency is also concerned that use of these ultrasound devices may result in a delay in seeking medical attention for a serious problem.
At this time, the FDA recommends that health care providers warn patients not to buy or use RoyalVibe Health, CellQuicken, or Well-Being Reality ultrasound medical devices. The FDA is currently working with RoyalVibe Health, who also operates CellQuicken and Well-Being Reality, to make sure it corrects its violations.
Adverse events related to the use of medical devices should be reported to the FDA’s MedWatch program.
References:
US Food and Drug Administration. Do not use RoyalVibe Health, CellQuicken, or Well-Being Reality ultrasound medical devices: FDA safety communication. July 17, 2023.
REFERENCE: MPR (Medical Professionals Reference); 18 JUL 2023; Diana Ernst, RPh