The FDA registers medical devices under a 510K system. The ReBuilder carries two registrations: K844085 & K882980. If you go to the FDA website, sometimes they ask for the K in front of the number and sometimes not. Be sure to try both in your confirmation search.

Below is a screen shot of the page that will come up if your search is entered successfully. Notice that the name of the correspondent is the same; David B. Phillips, and the name of the original company is Micromed of Vermont which was subsequently merged into ReBuilder Medical Inc.