Ultrasound
RoyalVibe HealthAbout
This business has 1 alert
Important information
- Additional Info:On November 18, 2022, the Food & Drug Administration (FDA), sent a Warning Letter to Dr. Raymond L. Venter, CEO of RoyalVibe Health Ltd. The FDA warned Dr. Venter that his business was found to be in violation of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(h), for selling adulterated devices intended to diagnose, treat, cure, or prevent many serious health conditions.
The FDA noted the following devices are advertised in violation of the FDA Act: RoyalVibe Bioresonance Focused Ultrasound Generator, Envirovibe Water Restructuring Pad, CellQuicken Analyzer, Therapy Balls Spine Alignment, BrainVibe Neuroplasticity Program, and the RoyalVibe Application.
Additionally, FDA notes that the business "denied and/or limited an inspection of" the company's establishment where the firm's devices are processed, packed, and/or held.
In response to the FDA letter, on July 7, 2022, the business indicated it "will cease offering the RoyalVibe products for sale in the United States" until it complies with FDA regulations.
www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royalvibe-health-ltd-639553-11182022
Business Details
- Local BBB:
- BBB serving North Central Texas
- BBB File Opened:
- 8/24/2021
- Alternate Names:
- CellQuicken
- RoyalVibe Health Ltd
- Well-Being Reality
- Business Management:
- Jackie Nel, Executive Assistant
Additional Contact Information
- Principal Contacts
- Dr. Raymond Venter, Owner
- Customer Contacts
- Dr. Raymond Venter, Owner
- Jackie Nel, Executive Assistant
- Ryno Van Tonder, Attorney
- Additional Phone Numbers
- Other Phone: (832) 742-6292
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