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It is not FDA-approved in the United States

Mitochondrial dysfunction is a critical factor in the progression of heart failure

This number has to be followed to the letter in most cases since a change in voltage equates to a change in motor RPM and will require changing the gearing but more likely the motor to a higher or lower KV rating - not something I want to get into in this write-up (I cover it in my setup & tips eBook)