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  • Writer's pictureMichelle Shank

Unapproved Ultrasound Devices: Warning from the FDA

Updated: Apr 2



The FDA issued a warning in July against a Texas manufacturer and distributor by RoyalVibe Health, CellQuicken, or Well-Being Reality. The devices have not been reviewed by the FDA, so 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.


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.


The FDA is asking caregivers and the medical community to avoid using ultrasound devices that have not been approved.


Unapproved Devices

The devices in question are from RoyalVibe Health, CellQuicken, and Well-Being Reality. They market the ultrasound devices for medical purposes that are provided by monthly or annual lease.


The organizations were issued a warning letter after they refused to let a FDA inspector into their facility.


After receiving the warning letter in July 2022, the organizations agreed to cease offering products in the United States until they are in compliance. However, currently they still have websites that are live and appear to offer the devices for sale in the US. The organizations have also not addressed devices that are currently in the homes of consumers.


False Claims

After a year of non-compliance and refusing to cooperate, the FDA has issued a warning to consumers that the devices are not approved and can lead to adverse medical

All three companies claim that their products and services can help improve health and well-being. However, there is no scientific evidence to support these claims. In fact, some of the claims made by these companies are false or misleading.


For example, RoyalVibe Health claims that its products can cure cancer, which is not true. CellQuicken claims that its product can increase energy levels, but there is no scientific evidence to support this claim. Well-Being Reality claims that its virtual reality experience can help users lose weight, but there is no scientific evidence to support this claim.


After a year of non-compliance and refusing to cooperate, the FDA has issued a warning to consumers that the devices and products are not approved and can lead to adverse medical effects.


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