FDA seeks to enjoin Universal Management from Stimulator device distribution.
This article was originally published in The Gray Sheet
UNIVERSAL MANAGEMENT SERVICES, INC. SPARKS FDA INJUNCTION FILING seeking to halt the firm's continued distribution of its electrical stimulator devices. The Dec. 21 complaint, filed at the U.S. District Court for the Northern District of Ohio, Cleveland, alleges that Akron, Ohio-based Universal Management never obtained the requisite premarket approval for The Stimulator and The Xtender, products that FDA says consist of modified gas grill igniters purchased from outside vendors.
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