Product code
OBV: Eating disorder conditioning tool
FDA product code · Class II · Neurology
Key facts
| Product code | OBV |
|---|---|
| Device | Eating disorder conditioning tool |
| Device class | Class II |
| Regulation number | 882.5060 |
| Review panel | Neurology |
| Medical specialty | Neurology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | 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. |
At a glance
- None 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database