Heat Wrap Device Safety With Age and Body Fat

AN OPEN LABEL STUDY TO COMPARE THE EFFECTS OF AGE AND BODY FAT ON THE SAFETY OF TWO HEAT WRAP DEVICES IN HEALTHY SUBJECTS

This study is designed to compare the safety, as measured by skin findings and adverse events, of two different heat devices in elderly, overweight, and elderly and overweight subjects.

Safety measurements

Inclusion Criteria:

• Males or females in generally good health, and who are either 18-54 years of age with a body mass index of ≥ 30 kg/m2
• or 55-84 years of age and with a body mass index ≥ 30 kg/m2 or < 30 kg/m2
• Females who are not pregnant or breastfeeding
• Subject is medically cleared for study participation

Exclusion Criteria:

• No sensitivitiy or allergy to device components in contact with skin
• Diabetes
• Any active skin disease or tattoos at the test site that would affect participation