Eating Disorder Conditioning Tool
The Eating Disorder Conditioning Tool (product code OBV) is a neurological medical device that non-invasively measures the mass of food consumed during a meal and provides real-time feedback on eating rate, patient satiety, and eating patterns to support behavioral modification in patients with eating disorders. It is intended as a therapeutic conditioning aid rather than a diagnostic device. This device is FDA Class 2 under regulation 882.5060 in the Neurology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
Basic Information
- Product Code
- OBV
- Device Class
- FDA class 2
- Regulation Number
- 882.5060
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN070014 | MANDOMETER III | Mar 31, 2011 | Unknown | AB MANDO |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.