FDA-Device2023-10-18Class II
CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls
RoyalVibe Health Ltd.
Hazard
Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance characteristics have not been adequately established. There is a possibility of customers' reliance on marketing claims which could cause the user to forgo medical treatment resulting in health consequences.
Sold states
US: MI, PA, TX, GA, OH, CA, FL, NY, NH, UT, AL, WA. WI, MN, MA, NM, IA, MD, IL, SC, NJ, NC, NV, TN, AZ, OR, OK, LA, OR, NE, ME, CO, MS, MT, CT, KY, HI, IN, DC
Affected count
564
Manufactured in
1095 Evergreen Cir Ste 200, N/A, The Woodlands, TX, United States
Products
CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0082-2024Don't want to check this manually?
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