FDA Warns Against Use of Unauthorized Consumer Ultrasound Devices

July 18, 2023 — The U.S. Food and Drug Administration (FDA) is warning consumers not to use ultrasound medical devices manufactured and distributed by RoyalVibe Health, CellQuicken, or Well-Being Reality. The devices have not been reviewed by the FDA. The safety and effectiveness of these devices have not been established to diagnose, treat, or cure medical conditions. Using these medical devices may result in adverse effects, including pain, bruising, burns, scarring, nerve damage, muscle weakness, or numbness.  

The FDA is concerned that consumers may be using these medical devices instead of seeking care from a health care professional. Delaying health care of a medical condition can be life-threatening, allow disease progression, and increase your risk of sickness or injury. 

Recommendations for Consumers and Patients 

• Do not buy or use RoyalVibe Health, CellQuicken, or Well-Being Reality ultrasound medical devices. 
• Be aware that the safety and effectiveness of these medical devices have not been established to diagnose, treat, or cure medical conditions. 
• 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. 
• 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 

• 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. 
• Review the Recommendations for Consumers and Patients with patients who have used the medical devices. 

Medical Device Description  

RoyalVibe Health, CellQuicken, Well-Being Reality, and potentially other companies, market these medical devices for use as focused ultrasound technology for medical purposes. The devices are typically provided in kits by monthly or annual lease. More information about these unauthorized medical devices is in the warning letter issued by the FDA.  

RoyalVibe Health, CellQuicken, and Well-Being Reality Ultrasound Medical Devices Are Not FDA-Authorized 

RoyalVibe Health, CellQuicken, Well-Being Reality, and potentially other companies, have marketed these medical devices that were intended to diagnose, treat, and cure several medical conditions, including cancer, diabetes, heart disease, Parkinson’s disease, and depression. The RoyalVibe Health, CellQuicken, and Well-Being Reality ultrasound medical devices have not been reviewed or authorized for marketing by the FDA. The safety and effectiveness of these devices has not been established. 

The FDA is aware of the following medical devices sold in kits  

• Brainvibe Neuroplasticity Visual Program 
• CellQuicken Analyzer (Smart-Watch and Software) 
• Envirovibe Water Restructuring Pad 
• RoyalVibe Application 
• RoyalVibe Therapy Balls 
• RoyalVibe Ultrasound Generator 

To find information about devices that the FDA has cleared or approved, see Products and Medical Procedures. 

FDA Actions 

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 are 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. 

Reporting Problems with a Medical Device 

If you have problems with a medical device or experience any adverse events from use of a medical device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.  

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.  

Prompt reporting can help the FDA identify and better understand the risks associated with the medical devices and improve patient safety.

Questions? 

If you have questions, Contact Us – Division of Industry and Consumer Education (DICE).