Our device would fit into a class two FDA device category as it is non-life supporting, non-implantable device. We will submit a 510(k) premarket notification for a cost of $11,000. 

The set mechanical standards for ECG cables and leadwires prevents the cross-connect of patient leads, which would cause the leads to potentially come in contact with a power source. In terms of sanitation, the cable material must be able to withstand being cleaned at least 15 times. 

Our device meets these regulations by having the universal ECG connection interface between the cables and the ECG machine. This is achieved by implementing a rotary connection between the cables in the spool and the cable end connecting to the ECG machine. 
Our device will be using already market approved cables that can withstand sanitation methods classified under the “wipe down” category. The cables will generally be passing through the sponge once or twice before the sponge is replaced. Below is an example of what our FDA approval would look like.