The QuantumPulse (http://thequantumpulse.com) is a machine that does something, what that something is I haven't a clue because the current website is vague to the point of being blank. The creator Gene Koonce claims that the QuantumPulse is not a medical device, but hunting down testimonials for the device that used to be part of his website would seem to suggest that people are using almost exclusively as a medical device (VIBE Machine testimonials 2003) in stark contrast to his claims.
What makes Gene Koonce qualified to make a machine that allegedly manipulates the human body? According to his website, nothing. Gene has no medical training, he may not even be CPR certified, so I guess he's really not qualified at all. But Gene is an electronics repairman in Colorado, so if your DVD player has the sniffles he might be able to fix that.
The QuantumPulse was formerly known as the VIBE Machine (http://vibemachine.com). Neither machine is FDA approved and in November 2007 the FDA investigated Gene Koonce's operation and in 2008 sent him a letter concerning the VIBE Machine (http://www.casewatch.org/fdawarning/prod/2008/vibe.shtml) It appears that the FDA, based on the information Gene Koonce has provided, does indeed consider it a medical device.
Gene Koonce claims he has subjected the VIBE Machine to clinical studies, but in an e-mail written to me, Gene claims that the FDA ordered him to remove the studies from the Internet. Looking at an old version of his website I could see three studies listed (vibemachine.com Clinical Studies page (2007)). One about anti-aging, one about depression and one about Biochemical Measures of Human DNA. The studies are not available and I had no luck finding them elsewhere.
But despite not having the studies available I was able to determine who conducted two of the studies. Dr. Norman Shealy and Dr. Ginger Bowler of Holos University conducted the anti-aging study and Dr. Ginger Bowler conducted the depression study. But a few problems cropped up from just these details.
Holos University (http://www.holosuniversity.org) is not an accredited university. You can search for accredited institutions here; http://www.ope.ed.gov/accreditation/Search.aspx and check for yourself. Holos University is a religious universities and offers degrees in theology, for example a Th.D, which is a doctorate in theology (http://en.wikipedia.org/wiki/Th.D). Application of a Th.D does not seem to be clinical studies of medical devices. Under Missouri law religious institutions are exempt from regulation (http://www.dhe.mo.gov/propschoolinfo.shtml) and that would be the plausible explanation why Holos operates out of Missouri. Apparently in Missouri all you have to do is claim religion, follow their religious exemption rules and you can do whatever you want. It appears from the Th.D's offered by Holos that religion, in the traditional sense, is not the focus of Holos University, but rather various forms of alternative and new age "medicine".
http://www.chea.org/degreemills/frmStates.htm has more information on accreditation and diploma mills with state by state links. Several states, notably Maine, Michigan, Oregon and Texas maintain lists of unaccredited schools and Holos University is listed on all four. Many other states simply refer to the lists maintained by states like Maine, Michigan, Oregon and Texas. It is important to note that degrees from unaccredited schools are not recognized or legal to use in many states.
Holos University was founded by Dr. Norman Shealy (http://www.normshealy.com) who is also the president of the university. Shealy appears to have a legitimate Ph.D from an actual school. Because of his education background and because he went to the trouble of starting up his own university I assume he ought to have some idea what accreditation is and what it means. It would be pretty third rate to start up a university and not research accreditation, right? Shealy's biography makes a point to mention that Holos University is accredited by New Thought Accreditation Commission (http://www.newthoughtac.org). But their endorsement of his university means nothing. So is Shealy being deceptive? If you ask him if Holos University is accredited, does he say yes? My opinion concerning this is pessimistic.
Ginger Bowler (http://gingerbowler.com) holds a Th.D from Holos University and Ph.D in philosophy from Greenwich University (where Shealy is also Professor Emeritus of Energy Medicine). The problem is Greenwich University is also unaccredited. In fact it was denied accreditation by the Australian government (http://www.dest.gov.au/archive/highered/enews/03/enews03.htm) & (http://en.wikipedia.org/wiki/Greenwich_University). It closed up shop shortly afterward and then re-opened up in Pakistan years later. Ginger Bowler might not be aware that her unaccredited unrecognized degrees are worthless, but for that to be true I would have to believe that she is mentally handicapped to the point of needing reminded to breathe so as not to suffocate. I do not hold that belief so I can only assume that she is aware of it and calls herself doctor dishonestly under the premise that her target demographic will never do the research that would uncover the truth.
These facts would seem explain why the FDA ordered Gene Koonce to remove the "clinical studies" for the VIBE Machine from the Internet. It just might be misrepresentation to claim to have clinical studies when the source of those studies is an unrecognized, unregulated, unaccredited university or when researchers doing the studies turn out to not have any sort of recognizable qualification to be conducting medical research.
I guess the question is: Should you trust an electronics repairman with your health and well being? It's half-time and the situation doesn't look good.
When the FDA sent out their warning letter to Gene in April of 2008 the VIBE Machine suddenly disappeared and was replaced by the QuantumPulse. The QuantumPulse appears to be an identical device in form and function to the VIBE Machine. One might conclude that Gene was running damage control and changing tack to try and slip through the FDA nets.
The FDA issued a Class 1 recall for the VIBE Machine (Class 1 Recall) and a Class 2 recall for the QuantumPulse (Class 2 Recall). These recalls were issued because of various claims made by Gene Koonce on his website and testimonials he had on his website and in materials related to the VIBE Machine and the QuantumPulse.
Stephen Barret, M.D. wrote about the device here: http://www.devicewatch.org/reports/vibe/vibe.shtml which sums up the situation much more cleanly and expertly than I can.
The QuantumPulse website has several hallmarks of classic quackery. The website is vague, full of techno-babble and lacks any real information. Also, despite the fact that the device is not FDA approved and despite Gene's run-ins with the FDA, the first thing you are greeted with on the website is a location finder to find the nearest QuantumPulse center. The mentality seems to be "sell first, prove later" and it is commonplace in new age/alternative medicine ventures. Finally, the QuantumPulse website mentions quantum mechanics and whenever someone mentions quantum mechanics to validate or explain their product, it is, without fail, a telltale sign of bullshit. But I have to comment that even the way in which quantum mechanics is mentioned on the website is baffling, it's just some random paragraph tossed in at the end seemingly unconnected to the previous paragraphs (http://www.thequantumpulse.com/how_it_works.htm).
This is what I will say about quantum mechanics; It is a legitimate scientific field of study. It's complex and counter-intuitive. It is a term many people have heard mentioned, perhaps on a science documentary or maybe in a magazine article. But most people on the planet lack sufficient science education in underlying principles that would make quantum mechanics familiar and commonly understood. People just know that it's some sort of complicated science thing and that is usually the extent of their expertise.
Meanwhile, quacks are never going to run into a person who going to be able to intelligently explain why their claims about quantum mechanics are bunk, certainly not on a day to day basis. And that's what makes it the perfect term for quacks to hijack and subvert. It's safe, it's glamorous and, considering how widespread quack use of "quantum mechanics" is, very profitable.
Gene Koonce is either dishonest or misguided, take your pick. It doesn't seem like you ought to trust this particular electronics repairman with your health at all.