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SmartByte Device
Custom made oral device used during meals to reduce the capacity of the oral cavity and slow/reduce food intake.
Details
Device typeOral intake restriction kit: A collection of devices intended to help reduce oral caloric intake for a patient undergoing a weight loss program. It includes a custom-made oral intake restrictor with integrated microsensor designed to reduce the oral capacity for food and to measure/record the usage of the device to provide data to enable the patient or their healthcare provider monitor progress on-line, and a microsensor reader. This kit is intended for single-patient use only (i.e., the patient from whom the palate impression was taken for the customization of the oral intake restrictor) and contains reusable devices.
FDA categoryOral Removable Retainer For Weight Management
Device ID00860001615326
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information