RoyalVibe Health Ltd.

FDA Regulatory Profile

RoyalVibe Health Ltd. appears in FDA public data with 1 recall, 0 510(k) clearances, 1 FDA inspection, and 1 compliance action on record. Its most recent recall (Z-0082-2024, Class II) was initiated on August 30, 2023.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
1
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0082-2024Class IICellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, EnvirAugust 30, 2023