I'm not qualified to answer you excellent question. You'll have to ask Tom, he has a lot of medical experience... In my opinion, my only guess is the companies that do the device manufacturing need a little lead time for the orders, the SurgeLine devices are the same exact item as the high end devices except the SurgeLine name is on our product. It the same German company doing our products,. You can read about this from the early posts.... How cool is that? Same product at a 60% cost saving...