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Feds move to seize massage devices

This article was originally published in The Gray Sheet

Executive Summary

Separate complaints filed in the U.S. District Court in New Haven, Conn. and the U.S. District Court for the Western District of New York on June 7 and June 8, respectively, allege that Dr. Ho's Double Massage and Dr. Ho's Muscle Massage muscle stimulators are adulterated and misbranded. FDA says that the unapproved Class III devices - owned by Canadian importer Universal Academy - have not been evaluated for safety and efficacy, yet they are labeled for use to treat serious medical conditions. Approximately $3.7 mil. worth of product has been seized from facilities in Buffalo, N.Y. and Meriden, Conn. where the stimulators were assembled and stored prior to sale, according to FDA. The case is being prosecuted by Assistant U.S. Attorney William Brown, Jr. and FDA Office of Chief Counsel trial attorney Jennifer Caruso...
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