On July 17th, the U.S. Food and Drug Administration (FDA) announced a ban on the use of ultrasound medical devices manufactured and distributed by RoyalVibe Health, CellQuicken, or Well-Being Reality. These devices have not undergone FDA review and have not demonstrated their safety and efficacy in diagnosing, treating, or curing medical conditions. The FDA is particularly concerned about the possibility of consumers using these medical devices without healthcare professionals' guidance.
Recommendations for Consumers and Patients
1. Do not buy or use RoyalVibe Health, CellQuicken, or Well-Being Reality ultrasound medical devices.
2. Be aware that the safety and effectiveness of these medical devices have not been established to diagnose, treat, or cure medical conditions.
3. Talk with a health care provider about any concerns you have about your health. Do not delay seeking professional health care for a medical condition.
4. Get medical help if you have adverse effects from using these medical devices. Using focused ultrasound technology may result in adverse effects, including pain, bruising, burns, scarring, nerve damage, muscle weakness, or numbness.
Recommendations for Health Care Providers
1. Tell your patients not to use RoyalVibe Health, CellQuicken, or Well-Being Reality ultrasound devices. These devices have not been reviewed by the FDA and have not been shown to be safe or effective to diagnose, treat, or cure medical conditions such as cancer, diabetes, heart disease, Parkinson’s disease, and depression.
2. Review the Recommendations for Consumers and Patients with patients who have used the medical devices.
The FDA issued a warning letter noting the firms’ violations to Dr. Raymond L. Venter, CEO of RoyalVibe Health, who also operates CellQuicken and Well-Being Reality. Among the violations noted is the lack of FDA 510(k) clearance or premarket approval (PMA) for its ultrasound medical devices. The FDA continues to work with the company to assure that it corrects its violations and will update the public if significant new information becomes available.
FDA encourages voluntary reporting of issues and adverse effects related to medical device usage. This reporting system helps the FDA monitor the safety and performance of medical devices, identify potential problems, and take appropriate actions to protect public health.
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