FDA Warns Consumers to Steer Clear of RoyalVibe Ultrasound Devices

Using these medical devices may result in adverse effects, including pain, bruising, burns, scarring, nerve damage, muscle weakness, or numbness.

FDA

Jul 17, 2023

RoyalVibe

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