Grapefruit USA Inc (GPFT)

[alexdhcfx]

Off the shelf is being used differently then they were originally designed to do. If you run anyone of these off the self parts differently then they were approved for then you all you are doing is using off the shelf parts to do something they were never designed to function. So equivalence is not been maintained since their use is not for their FDA approved intended use. I think of it like this.

If I strap a rocket on a new car, a rocket that has been tested and has been approved to be used a a rocket, can I just say that its no longer a rocket but a car engine or take it from the other side can I just go out say my car is now a rocket because it has a rocket engine on it.

Well the car is off the shelf, the rocket is off the shelf, but a rocket car is not off the shelf. The components are not being used for their intended use or purpose or being used in a different way then they were approved for.

So if IMGG could have problems with the intended use of the DVIS and combining that intended use to stay compliant for the off the shelf parts intended use. if it can't maintain that equivalence with the off the shelf parts then IMGG has built a one of a kind machine and that could lead us down a longer road.