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.
| Device Type ID | 3761 |
| Device Name | Eating Disorder Conditioning Tool |
| 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 |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.5060 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OBV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3761 |
| Device | Eating Disorder Conditioning Tool |
| Product Code | OBV |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 882.5060 [🔎] |