Company / News

Is this body scanner a medical device?

Is this body scanner a medical device?

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

AreYouMakingP1 AreYouMakingP2 AreYouMakingP3 AreYouMakingP4 AreYouMakingP5

download whitepaper

Related News

Voler Record Keeping Proves Valuable

In 2001 we built a control system for a machine...

An Interesting CBInsight Article About Medical...

In CBInsight's article "Redefining The Future of Medicine: 72 Medical Device...

Webinar: Investigating Your Hypothesis

The human body is a complex dynamic system that offers...

Newsletter Sign Up
Chatbot
chat-icon
clse-1
Get Expert Consulting

Voler is really good at identifying risks and finding the best way to do a project on-time, on spec, and easy to manufacture.