United States v. Two Units, More or Less, of an Article or Device, Consisting of a Power Unit & a Chair

ORDER

The memorandum disposition filed November 23, 1994, is redesignated as an authored opinion by Judge Farris.

OPINION

Kyttaron Energy Corporation appeals from the district court’s summary judgment for the United States. Kyttaron contends that the district court erred in ruling that the seized medical devices were subject to forfeiture under the Food, Drug, and Cosmetic Act for failure to maintain adequate records and for mislabeling. We have jurisdiction under 28 U.S.C. § 1291 . We affirm.

*481 I. BACKGROUND

Evans Rapsomanikis is the founder and CEO of Kyttaron Energy Corporation, which is licensed to conduct business in California and Nevada. Kyttaron manufactures a device known as a Bio-Ionic System. The BIS device is an electrical machine and accompanying reclining chair that applies electromagnetic currents to the human body through adhesive electrode pads and coils. Kyttaron maintains that the Bio-Ionic System produces “free electrons” within the body, thereby stimulating and enhancing the body’s natural healing processes.

The FDA received several reports that Kyttaron was promoting the device as a cure for cancer, AIDS, paraplegia, heart disease, muscular…