As Brian mentioned it is actually illegal to infer that the FDA has "approved" of a medical device for any purpose (or in some way construed that it has FDA approval or endorsement). One may only claim that a device has been "cleared for market" by the agency. The FDA routinely issues warning letters for this violation and it is considered "misbranding". They are VERY strict on this. Typically they issue a form letter with the FDA "clearance to market" (or SE "substantial equivalence" letter) letter detailing the exact labeling that a company may use. If I was at Vitalstim I would have fired the regulatory person(s) who allowed this to slip through. ALL marketing literature, including printed, web sites and even verbal claims made, are subject to this regulation.

(and it is actually a "premarket notification" not "approval")

ONLY drugs are "approved" by the FDA.