Food and Drug Administration and state and local regulatory agencies. You must be an authorized purchaser (have a doctor's recommendation). The item "Exogen 4000 bone healing ultrasound Guaranteed to run 091150" is in sale since Sunday, September 18, 2016. This item is in the category "Baby\Baby Gear\Activity Centers". The seller is "friedmushrooms" and is located in Cookeville, Tennessee.This item can be shipped to United States.