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Rebuilder Exposed – Read this and educate yourself!
If Rebuilder is FDA cleared or approved as a treatment for Neuropathy or Cancer or HIV/Aids or the other 18 medical conditions listed on this "Rebuilder" website as at June 17th, 2010, (http://www.neuropathydiabetic.com/fda-approved/), paperwork from the FDA supporting this statement should be available but David Phillips of Rebuilder Medical Technologies was willing but UNABLE to provide this when asked.
In a recent telephone call, David Phillips of Rebuilder Medical Technologies Inc claimed that he knew nothing of the above website. Presumably, as the manufacturer of Rebuilder, he would take immediate steps to have this situation corrected before the FDA took action, as has been done against Rebuilder Medical Technologies Inc several times in the recent past and evidenced from the links below.
There are no contact details on the above website. No telephone and no address. If you're still wondering, so are we. Who is hiding behind this website? Is it simply a sham website promoting Rebuilder in violation of the FDA rules? Where do the "order now" links lead to?
Why on this page (http://www.neuropathydiabetic.com/products/rebuilder-300/) are there email links and references to rebuildermedical.com? Why does this statement, "Neuropathy Diabetic does not claim to treat, diagnose, or affect any disease or part of the human body" appear next to the excerpt below on EVERY page of the website?
These are legitimate questions begging for a legitimate answer.
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Excerpt from the Rebuilder website:
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Rebuilder was FDA cleared as a TENS device because that was how the 510k application was written, as a "substantially equivalent" device. It would appear from the wave form and other device operational statements on the main Rebuilder website that the Rebuilder unit is in fact a device substantially different than what it was cleared by the FDA as, thus a new 510k is or should be required as the device would be "substantially" different at that point.
Either the Rebuilder is a simple TENS device with a limited number of claims or it should be subject to a new 510k application citing the 21 medical claims AND supported by evidenced based clinical studies.
It simply cannot be both.
Reports and warning letters
http://www.sciencebasedmedicine.org/?p=190
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048206.htm
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm165237.htm
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