MANDOMETER III
Device Facts
| Record ID | DEN070014 |
|---|---|
| Device Name | MANDOMETER III |
| Applicant | Ab Mando |
| Product Code | OBV · Neurology |
| Decision Date | Mar 31, 2011 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 882.5060 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
