The calmare equipment is a TENS machine so whatever the protocol and electrode placing being used by any given doctor or operator, it will function in exactly the way that a normal, multi-channel TENS machine does - electrode pads attached to the skin and an electric current run through the electrodes which is controlled and adjusted by the main unit. It contains pre-programmed cycles.

I'm not saying this to upset anyone or create any arguments about the nature of this particular treatment. I am very aware of how controversial it is and how many arguments there are about it. I am only relaying the absolute facts about the equipment being used. In front of me I have copies of their FDA 510(k) Medical Device Application and the corresponding FDA Approval Letter and it is absolutely a matter of indisputable fact that this device is a nothing more than a simple multi-channel TENS machine. That is what the manufacturers of the equipment have themselves said that it is. In fact, they have based their 510(k) application on "Predicate Devices" which are 2 specific, listed existing models of TENS machines already manufactured by other companies which were already on the market at the time of their application. This allows them to get their approval more easily - they apply on the basis that their device is equivalent in construction and effect to a device that is already on the market and already has FDA approval.

The 510(k) makes it clear that the device is only designed to provide symptomatic relief of pain. That, as you will all know, is exactly what any simple multi-channel TENS machine which you can purchase from a high street chemist or on the internet, claims to be able to do.