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.

Contraindications
Eating Disorder: Do not use the device if you have eating disorders such as anorexia nervosa (abnormally low body weight, intense fear of gaining weight, and distorted perception of body weight), or bulimia nervosa (eat large amounts of food and then purge (e.g., vomit) to not gain weight). The device is a weight management aid and is contraindicated (means do not use) in individuals with eating disorders. There may be safety risks if you have an eating disorder and use this device.

Pregnancy: 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 safety risks if you are pregnant and use this device.

Risk Statement
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.

Important: For full safety information please click here, talk with your doctor, or call Customer Support at 978-655-4044.

CAUTION: Rx only.