FDA product code OBV: Eating Disorder Conditioning Tool
OBV is the FDA product code for eating disorder conditioning tool. It is a Class II device, regulated under 21 CFR 882.5060 and reviewed by the Neurology panel. Devices under OBV reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Eating Disorder Conditioning Tool |
| Device class | Class II |
| Regulation | 21 CFR 882.5060 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for OBV devices
openFDA lists no recalls for product code OBV.
Frequently asked questions
What is FDA product code OBV?
OBV is the FDA product code for eating disorder conditioning tool. It is a Class II device, regulated under 21 CFR 882.5060 and reviewed by the Neurology panel.
What device class is OBV?
Class II, regulation 21 CFR 882.5060. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OBV
- Run a recall and safety report across every OBV manufacturer
- Watch product code OBV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.