FDA product code ONY
Oral Removable Retainer For Weight Management
Gastroenterology, UrologyClass 221 CFR 876.5981
US regulatory classifications
- US Risk Class (FDA)
- Class 2
- Medical specialty
- Gastroenterology, Urology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
A removable oral device used during meals to limit food intake.
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About this record
Oral Removable Retainer For Weight Management is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.