Omron’s Body Composition Monitor and Scale measures 7 fitness indicators including body fat percentage, body mass index (BMI), skeletal muscle, resting metabolism, visceral fat, body age and body weight.
Walt’s answer:
This is not a medical device, although Omron makes many consumer products that are medical devices, such as blood pressure monitors. The measurement of body impedance is not a diagnostic test that is used to identify disease. The device includes a weight scale, which is also not a medical device. The claims are that it makes measurements, but there is no claim of diagnosis or treatment of any disease. They claim it will help you meet your fitness goals, which clearly is not a medical device.
Download our “Are you making a medical device?” Whitepaper.

Discover:
- Is it a medical device?
- FDA updates on mobile apps
- Mobile medical apps regulated by the FDA
- Classification of medical devices
Here is a sneak peek:
