Replies to post #8898 on Grapefruit USA Inc (GPFT)

[Chemic76spirit]

Something about the structural integrity of the Dominion, and vibration caused by harmonics of moving parts? I believe is a non issue. I would think there should be a proptype in the shop that should have been cycling non-stop during this whole process, if there isn't there should be now , so Dean can log the life time expectancy with contious use, even though it may only be used several hours at a time. I personally don't get why the FDA has a say {in anything other thatn is this thing safe to use}, the rest is just BS. Dean should have documentation of hours of service expected per unit though,{even if the FDA wasn't asking for it].

[Nina4900]

I thought it was only about needing more documentation or information detail on harmonics/vibration, not that there was an issue or problem pointed out. Perhaps someone has more detail of the cc. I believe he discussed it within the first few minutes as I remember, so I might go back and check his wording. Also might email Mike Nessen.

[docmts2]

Surely they can quickly and easily verify all those specifications. After all, wouldn't vibration and harmonics be more about image quality than patient comfort? The patient platform is the fixed, stationary part once the brakes are put on its wheels. Sounds like this new person is either eagerly over doing it or throwing a wrench in the works for whatever reason.