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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