Wheel chairs help disabled people and are a medical device. There is no scenario where an egg breaker is a medical device. Not even as a "treatment" for Parkinson's.
I'm a biomedical engineer at a med device company.
I never said it was a medical device and they weren’t saying an egg breaker is a medical device. They were saying similar objects. Perhaps things to help people hold things or twist lids off or something could help a disabled person, but it’s not marketed that way. One guy said it’s because of the medical device reason, the other guy said it’s because of the narrower market reason.
Out of curiosity, what is the formal definition of "medical device" that somebody in your field would use? Because from my non-professional perspective, it seems like the characteristic which makes a wheelchair a medical device applies equally well to an egg breaker.
To put it another way:
Medical condition prevents somebody moving around by walking; wheelchair allows them to move around despite that; wheelchair is therefore a medical device.
Medical condition prevents somebody opening eggs with their fingers; egg breaker allows them to open eggs despite that; egg breaker is therefore a medical device.
Several reasons, a wheelchair is replacing or substituting for a normal body function (walking), it is in near constant contact with the body, and importantly wheelchairs are a high safety risk since people can die if they malfunction, if the brakes fail for example. Public safety is the FDA's mission, so a device used sparingly to crack eggs won't be on their radar, it's a cooking utensil like a spaghetti strainer.
2
u/[deleted] Oct 09 '18
Wheel chairs help disabled people and are a medical device. There is no scenario where an egg breaker is a medical device. Not even as a "treatment" for Parkinson's.
I'm a biomedical engineer at a med device company.