RoyalVibe Health Ltd.
FDA Regulatory Profile
RoyalVibe Health Ltd. has 1 FDA recall, 1 inspection, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- Z-0082-2024 · Class II · Aug 30, 2023
- Latest inspection
- Jul 5, 2022 · OAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 1 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 1 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0082-2024 | Class II | CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe… | Aug 30, 2023 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jul 5, 2022 | The Woodlands, TX | Devices | Official Action Indicated (OAI) | 3022074304 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3022074304 | The Woodlands, TX | 1 | Jul 5, 2022 |