Important Safety Information
Indications for Use
The SmartByte Device is intended to aid in weight management in overweight to obese individuals. The device is indicated for individuals with a body mass index (BMI) in the range 27-35 kg/m2 in conjunction with behavioral modification instruction.
SmartByte does not work for everyone and individual results may vary. The most common complications, which occur in less than 2% of people, are soreness in the mouth, gagging upon insertion of the device or momentary gagging of food during device use.
The device is a weight management aid and is contraindicated (means do not use) in individuals with eating disorders. There may be additional safety risks if you have an eating disorder and use this device.
Do not use the device if you are pregnant. The device is a weight management aid and weight loss is contraindicated in pregnancy. There may be additional safety risks if you are pregnant and use this device.
For full safety information, please contact Customer Care at firstname.lastname@example.org.