| Device |
eating disorder conditioning tool |
| Regulation Description |
Conditioning tool for eating disorders. |
| 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. |
| Physical State |
A flat scale is connected to a monitor which records data and displays the food consumption rate. The monitor also prompts the user for satiety sensation and displays trend. |
| Technical Method |
Uses scale to meaure weight of plate during meal. Prompts user to provide feedback on satiety during meal. Provides display for actual and target food consumption rate. |
| Target Area |
brain and stomach |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | OBV |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Physical Medicine Devices
(DHT5B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.5060
|
|---|
| 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 |
