The ReBuilder is FDA Registered.
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.
To do this search:
1) visit this URL: www.fda.gov/search/databases.html
2) scroll down until you see this paragraph:
Medical Devices
510(k)s--Premarket Notifications (PMN)
Description: This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code. Summaries of safety and effectiveness information is available via the web interface for more recent records.
3) click on the blue link
4) enter K882980 in the top left box, and hit 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.
