Energy devices seized – Food and Drug Administration seizes high genki machine from the International Ki Institute of Health Management and research, Honolulu, Hawaii
The International Ki Institute of Health Management and Research in Honolulu called it a “high genki” machine, but to FDA, the so-called medical device was nothing more than high jinks.
In fact, FDA’s San Francisco district office displayed the device at an FDA building dedication ceremony last summer. It was exhibited along with other devices that “beeped, buzzed, gave a mild electric shock, and that was about all,” said Cindy Wolodkin, a public affairs specialist in FDA’s San Francisco office.
Promoters of the high genki machine had promised it could do much more, including treating diabetes, high blood pressure, muscular pain, arthritis, and other common medical problems. But FDA said it was an unapproved medical device that had been brought illegally into the country. So, on Nov. 9, 1993, under orders from the U.S. District Court for the District of Hawaii, at FDA’s request, U.S. marshals seized four high genki spot vibrators, three high genki junior machines, and one other similar device then in the state of Hawaii’s possession.
FDA became aware of the devices in June 1993, when officials from the Hawaii Department of Health’s food and drug branch asked the agency to take action against the devices at the International Ki Institute.
On June 9, investigator Robert Wesley, of the agency’s Honolulu resident post, and two state inspectors visited the Ki Institute. There, an employee told them that the institute used the high genki machines for “ki” therapy.
Literature at the clinic described ki as “life energy–the energy fields that pervade all matter both animate and inanimate.” Ki therapy aims to replenish that energy “to enable the body to work at its optimum level” and “help improve many modern day diseases,” the literature said.
The investigators observed employees using the devices on several people. One employee using the machine told the investigators she was treating the person for diabetes. She said the machines also were used to treat cancer, heart disease, stroke, and other illnesses.
The investigators spotted an assortment of the devices on the premises. They were told that the largest unit, which actually was two devices in one, sold for $6,000. A smaller device contained in what looked like a briefcase went for about $2,700. The smallest, called a high genki junior, sold for $325.
Employees told the investigators that the devices were brought in with luggage from Japan and not identified to U.S. Customs Service upon arrival as required. Because of this and the fact that the devices had not been approved by FDA, the state of Hawaii immediately issued a notice prohibiting further use, sale, dispensing, and promotion of the machines. The state immediately took possession of the machines on hand and requested that the institute recall all units previously sold.
In its July 7, 1993, recommendation for seizure, FDA noted that the high genki devices were under import alert as energy point stimulators and thus would not have been allowed in this country if their entry had been reviewed by FDA. However, FDA was not able to review the devices because the importer failed to request–and obtain–the required approval from FDA before bringing medical devices into the country.
FDA is unaware of any injuries or deaths from use of the high genki machines.
FDA’s San Francisco office has added the machines to a collection of other electrical stimulating devices that have been seized over the years because of their unproven medical claims.
COPYRIGHT 1994 U.S. Government Printing Office
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