In Brief: Stimulator consumer alert
This article was originally published in The Gray Sheet
Executive Summary
Stimulator consumer alert: Electrical "stimulator" device has not been approved by the agency and its manufacturers have not "complied with any FDA regulations" governing medical devices, FDA says in an Aug. 28 consumer alert. The device, which FDA says is an electric gas barbecue grill igniter outfitted with finger grips and an accessory called the Xtender, are promoted for relieving headaches, back pain, arthritis, stress, menstrual cramps, earaches, nosebleeds, flu and other ailments. FDA obtained a preliminary injunction against Universal Management Services and Natural Choice, both of Akron, Ohio, seeking to stop advertising, sale and distribution of the products in January. According to FDA staffers, the agency is investigating whether Universal Management is taking orders or selling the product in violation of the injunction, which was originally filed in December 1995 ("The Gray Sheet" Feb. 12, 1996, I&W-13). Of the six firms FDA identifies as having received warning letters in the past three years about marketing of the device (Natural Innovations, Canton, Ohio; Gandee Chiropractic Life Center, Akron, Ohio; Self-Care, Emeryville, Calif.; Magna Plus, Twinsburg, Ohio; Bright Marketing, Burlington, Iowa; and Crystaldyne, Scottsdale, Ariz.), two may have ties to Universal Management, the agency says. FDA believes two of the six firms have stopped selling the device...