ONY
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Oral Removable Retainer For Weight Management
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5981
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- A removable oral device used during meals to limit food intake.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SmartByte Device (K171165) | Scientific Intake | 2017-05-18 |
| Sensor Monitored Alimentary Restriction Therapy (SMART) Device (DEN150033) | Scientific Intake | 2016-09-26 |
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