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U.S. Department of Health and Human Services

Product Classification

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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 CodeOBV
Premarket Review Neuromodulation and Rehabilitation Devices (DHT5B)
Neuromodulation and Rehabilitation 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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible