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Eating Disorder Conditioning Tool

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5060
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5060 Conditioning tool for eating disorders

§ 882.5060 Conditioning tool for eating disorders.

(a) Identification. A conditioning tool for eating disorders is a prescription 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.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Nonclinical performance testing must demonstrate:

(i) Device measurement accuracy and repeatability; and

(ii) Device feedback accuracy.

(2) Software verification, validation, and hazard analysis must be performed.

(3) The patient-contacting components of the device must be demonstrated to be biocompatible.

(4) Performance testing must demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device.

(5) Labeling and patient labeling must be provided which includes the following:

(i) Information identifying and explaining how to use the device and its components; and

(ii) Information on how the device operates and the typical course of treatment.

[86 FR 68403, Dec. 2, 2021]

Eating Disorder Conditioning Tool

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5060
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5060 Conditioning tool for eating disorders

§ 882.5060 Conditioning tool for eating disorders.

(a) Identification. A conditioning tool for eating disorders is a prescription 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.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Nonclinical performance testing must demonstrate:

(i) Device measurement accuracy and repeatability; and

(ii) Device feedback accuracy.

(2) Software verification, validation, and hazard analysis must be performed.

(3) The patient-contacting components of the device must be demonstrated to be biocompatible.

(4) Performance testing must demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device.

(5) Labeling and patient labeling must be provided which includes the following:

(i) Information identifying and explaining how to use the device and its components; and

(ii) Information on how the device operates and the typical course of treatment.

[86 FR 68403, Dec. 2, 2021]