I agree with what you posted...
I think if Joe Noel knew how to word it like you just did he would have done it in stead of beating around the bush like he did below...
WOW!!!! – Today’s BIEL Announcement – Why It’s Important – I am Seriously Impressed by This and Upcoming Introductions
This is really simple. BIEL is announcing a new version of its device. It has higher power (10X) and operates at a different frequency. Most of the time companies want to have their new devices be very similar to the old devices so that the FDA will rubber stamp them into the existing clearance. BIEL does not want this because its current Class III clearance is an issue. It wants the new version to be viewed by the FDA as a different type of device – not another Class III device. The strategy is to have the device have the same attributes as an electric stimulator device, which is a Class II device. This new device does.
If you have been following BIEL for any length of time you should be having an Ahh-Ha moment!!! The main issue with FDA clearance is that ActiPatch and Allay are considered Class III devices. FDA does not seem to want to clear such devices for OTC use even though there is clear evidence of safety. The new device will be a Class II device, but will do much the same thing as the current devices – and maybe even do it better. Having that Ahh-Ha moment yet? You should be. Therefore, the new device should be a Class II with a MUCH easier clearance path. Ahh-Ha!!!!!