Device |
oral removable retainer for weight management |
Regulation Description |
Oral removable palatal space occupying device for weight management and/or weight loss. |
Definition |
A removable oral device used during meals to limit food intake. |
Physical State |
Stainless steel wire, electrical sensor and palatal mold (polymer) |
Technical Method |
Intraorally limits bite size |
Target Area |
Mouth |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | ONY |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
Submission Type |
510(k)
|
Regulation Number |
876.5981
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |