OBV — Eating Disorder Conditioning Tool Class II
FDA product code OBV covers "Eating Disorder Conditioning Tool", a Class II medical device regulated under 21 CFR 882.5060. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OBV
- Device Class
- Class II
- Regulation Number
- 882.5060
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
A conditioning tool for eating disorders is a medical device that non-invasively measures the mass of food eaten during a meal and provides feedback in the form of eating rate, patient satiety, and eating pattern information to the patient.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN070014 | ab mando | MANDOMETER III | March 31, 2011 |