Definition: A Removable Oral Device Used During Meals To Limit Food Intake.
| Device Type ID | 2081 |
| Device Name | Oral Removable Retainer For Weight Management |
| Physical State | Stainless Steel Wire, Electrical Sensor And Palatal Mold (polymer) |
| Technical Method | Intraorally Limits Bite Size |
| Target Area | Mouth |
| Regulation Description | Oral Removable Palatal Space Occupying Device For Weight Management And/or Weight Loss. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5981 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ONY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2081 |
| Device | Oral Removable Retainer For Weight Management |
| Product Code | ONY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Oral Removable Palatal Space Occupying Device For Weight Management And/or Weight Loss. |
| CFR Regulation Number | 876.5981 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SCIENTIFIC INTAKE | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |