You are 100% correct. And don't forget FDA approva

You are 100% correct. And don't forget FDA approval should be relatively easy. This is not a medication or controlled substance that we are talking about. From Zacks research report regarding IR Med and the pending FDA approval (italics mine):

 The FDA registration for PressureSafe is relatively straightforward and expedient as the device falls under the 510(k) regulatory process because it is considered a safe decision support device.