Recall Z-0082-2024— RoyalVibe Health Ltd.
Class II · Ongoing
Class II FDA medical device recall by RoyalVibe Health Ltd., initiated 2023-08-30. FDA's recall record names no specific 510(k) clearance for this event. Product: CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls. Reason: 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..
- Recalling firm
- RoyalVibe Health Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-30
- Firm location
- The Woodlands, TX, United States
Product description
CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.