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.


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		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. Back to ReBuilder Page Statements about neuropathy and others topics are for information only and should not in any way be used as a substitute for the advice of a physician. Statements about neuropathy and the ReBuilder have not been reviewed by the FDA. Suggestions and ideas presented here should not be interpreted as medical advice, meant for diagnosing illness, or for prescriptive purposes. The ReBuilder system’s electrical stimulation has been proven 95% effective in recent clinical studies in reducing and even reversing the symptoms of peripheral neuropathy.