Just a second, doctor. Consider this;
How to Determine if Your Product is a Medical Device
(excerpt)
Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas systems. Additionally, medical devices include in vitro diagnostic (IVD) products, such as reagents, test kits, and blood glucose meters.
Certain radiation-emitting electronic products that have a medical use or make medical claims are also considered medical devices. Examples of these include diagnostic ultrasound products, x-ray machines and medical lasers.
What say you?
You like to waste a lot of time on personal grudges I see.
It’s good for you to read, so I’ve done you a service.
Keep reading FDA guidances on medical device approval.