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.
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Note: This site is not intended to be part of the labeling for ReBuilder products. Please read all the instructions included with your shipment and always follow the specific suggestions of your physician for best results.
Doctors and clinics all over the world are recommending the ReBuilder Neuropathy Treatment System. Fast, safe, effective, proven. This site is not intended to be a solicitation for the purchase of securities. Nothing on this site is intended to be construed as "labeling" relative to the FDA. The FDA has not reviewed, approved or evaluated the data on this site.
Use of this site constitutes full agreement with our Terms of Use including the restriction of use by any government agency or personnel seeking to review this site for regulatory issues. This site is for informational purposes only. ReBuilder Medical does not claim to treat, diagnose, or affect any disease or part of the human body.
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