News | Ultrasound Imaging | July 18, 2023

FDA issues statement not to use RoyalVibe Health, CellQuicken, or Well-Being Reality ultrasound medical devices 

FDA issues statement not to use RoyalVibe Health, CellQuicken, or Well-Being Reality ultrasound medical 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)


Related Content

News | ASTRO

May 17, 2024 — Registration opens today for the American Society for Radiation Oncology's (ASTRO) 66th Annual Meeting ...

Time May 17, 2024
arrow
News | Enterprise Imaging

May 16, 2024 — AGFA HealthCare announced that St. Vincent’s Private Hospital in Dublin, Ireland, has chosen to implement ...

Time May 16, 2024
arrow
News | Artificial Intelligence

May 16, 2024 — deepc, the globally recognized digital medicine pioneer and market leader behind the leading AI operating ...

Time May 16, 2024
arrow
News | Enterprise Imaging

May 15, 2024 — etherFAX announced the expansion of its partnership with Hyland, a leading global provider of intelligent ...

Time May 15, 2024
arrow
News | Cybersecurity

May 13, 2024 — In the wake of the cybersecurity breach targeting the prominent healthcare system Ascension, a new study ...

Time May 13, 2024
arrow
News | Radiology Imaging

May 13, 2024 — National Basketball Association (NBA), the National Basketball Players Association (NBPA), and the Next ...

Time May 13, 2024
arrow
News | Radiation Oncology

May 10, 2024 — Mariana Oncology, a fully integrated biotechnology company pioneering a new era of radiopharmaceutical ...

Time May 10, 2024
arrow
News | ARRS

May 8, 2024 — Compared to males, women in radiology are at a consistently higher risk of not matching into diagnostic ...

Time May 08, 2024
arrow
News | Contrast Media

May 8, 2024 — Swedish biotech company Ascelia Pharma AB has announced that its liver imaging drug candidate, Orviglance ...

Time May 08, 2024
arrow
News | ARRS

May 7, 2024 — The American Roentgen Ray Society (ARRS) announced that Philip Costello, MD, the 118th ARRS President and ...

Time May 07, 2024
arrow
Subscribe Now