News Report identifies The Vibe Machine a/k/a The Quantum Pulse under FDA...(More)

News Report identifies The Vibe Machine a/k/a The Quantum Pulse under FDA investigation. http://www.fda.gov/foi/warning_letters/s6745c.htm Ref.# - DEN-08-12 Dear Mr. Koonce: During an inspection of your firm located in Greeley, Colorado, on November 5 through November 16, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the V.I.B.E., Vibrational Integrated Bio-photonic Energizer (VIBE) Machine. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required. This inspection revealed that you have not obtained marketing approval or clearance before you began offering your product for sale, which is a violation of the law. ...(Less)