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Unapproved Devices Seized

An Ohio judge recently ordered the destruction of 61 Relaxman Synchro-energizers--gadgets consisting of glasses, headphones, and a control box producing sound and flashing light patterns. The manufacturer had promoted and distributed the device as a solution to myriad health problems, without supporting documentation of their safety and effectiveness and without complying with FDA medical device regulations.
On Feb. 23, 1995, Judge Ann Aldrich, of the U.S. District Court for the Northern District of Ohio, ordered the destruction of the unapproved medical devices, manufactured by Meta Brain/Mind Biomedical Research Foundation, Cleveland, Ohio, and worth approximately $30,000.
FDA's investigation of Meta Brain began Sept. 1, 1992, when the agency's San Francisco district office received a consumer complaint that a Synchro-energizer device caused a seizure in a 21-year-old woman. The woman, who had never had a seizure before, had used the device as part of a work-related stress reduction seminar. A physician who examined the woman afterwards confirmed that she had had a seizure.
In response to the complaint, beginning on Nov. 9, FDA investigators Stephen J. Kilker and Donald F. Fernholz, from the agency's Brunswick, Ohio, resident post, inspected Meta Brain.
During the inspection, the investigators learned that the firm's owner, Krystina J. Rymsky, had not submitted a premarket approval application to FDA for the Relaxman and had not registered the firm with the agency. The investigators explained to Rymsky that because of these violations, FDA could initiate legal action against the goods, the firm, and the responsible individuals.
Rymsky said she would register the company and file premarket approval notifications. However, she never followed through.
During the inspection, the investigators collected labeling and promotional materials for the Relaxman. Jerilyn Glass, M.D., a neurologist with FDA's Center for Devices and Radiological Health, reviewed the materials and found numerous health claims for the device, including control of pain, habits and addictions, and improved digestion and sexual function.
According to the promotional literature, the Relaxman achieved these beneficial effects by changing electrical brainwave activity.
A search of the scientific literature through FDA's Medical Library revealed that no well-designed studies or investigations had been published in peer-reviewed scientific journals to demonstrate the safety or effectiveness of the Relaxman device for these purposes.
In addition, the promotional literature did not adequately warn about the danger of seizure. A statement in the device's user guide did warn that people with "any history whatsoever [of] epilepsy or brain seizures" should not use the device "except under the direct supervision and/or order of [a] licensed M.D., Ph.D., or other qualified health care professional." However, Glass says, the warning was inadequate, because it did not warn that all users, even those with no prior history of seizure or epilepsy, could be at risk.
On Dec. 11, 1992, Evelyn D. Forney, a compliance officer with FDA's Cincinnati district office, recommended to the agency's Center for Devices and Radiological Health that all Relaxman devices in Meta Brain's possession be seized.
The center agreed, but asked that the district verify that the firm was still selling the device. On May 11, 1993, FDA investigator Frederick M. Lochner called Meta Brain and requested information about the Relaxman. He received promotional materials similar to the ones collected during the November inspection.
On July 28, 1993, at FDA's request, a seizure complaint was filed in the U.S. District Court for the Northern District of Ohio. The complaint charged that the devices:

• had no approved application for premarket approval and were not exempt from this requirement
• had not been listed with FDA as required, and no premarket notification was provided to FDA
• had false or misleading labeling
• did not have adequate directions for use
• were a danger to health when used as recommended in the labeling
• lacked adequate warnings concerning potential health hazards.

The devices were seized on Aug. 3, 1993. Rymsky filed a response to the seizure admitting that the seized goods were devices, but generally denying the other allegations in the complaint.
On Nov. 22, 1994, the Justice Department, on FDA's behalf, filed a motion for summary judgment requesting the devices be condemned as adulterated and misbranded and be forfeited to the United States. The motion also requested that Rymsky pay all costs and fees as required by law. Rymsky did not respond, and on Feb. 23, 1995, the court granted the government's motion. At press time the devices were in possession of the U.S. marshals, awaiting destruction.
--Isadora B. Stehlin

that divice was under FDA attention . take caution . i remind you this forum is about FLOAT-TANKS not trance suit or else . Thank-you