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# FDA Warns About Using RoyalVibe Ultrasounds
- URL: https://www.fdaweb.com/fda-warns-about-using-royalvibe-ultrasounds/
- Published: 2023-07-17T12:00:00.000Z
- Updated: 2026-09-14T18:44:43.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154884

FDA has issued a warning against using ultrasound medical devices manufactured and distributed by RoyalVibe Health, and related companies CellQuicken and Well-Being Reality. The agency says the devices have not been reviewed for safety or effectiveness, and using them “may result in adverse effects, including pain, bruising, burns, scarring, nerve damage, muscle weakness, or numbness.”

Last year, FDA issued a [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royalvibe-health-ltd-639553-11182022?ref=fdaweb.com) about the the firms’ violations ([see earlier story](https://www.fdaweb.com/royalvibe-health-refused-inspection-fda/)). FDA says it “continues to work with the company to assure that it corrects its violations and will update the public if significant new information becomes available.”