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 [🔎] |