FDAnews Device Daily Bulletin

DEPARTMENT OF JUSTICE, FDA SEIZE MASSAGE PRODUCTS SOLD AS 'MEDICAL' DEVICES

June 14, 2006
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A company selling massage products as medical devices has drawn the ire of the Department of Justice (DOJ) and the FDA.

In two separate court filings, the U.S. Attorneys General for the Western District of New York and the District of Connecticut allege a Canadian importer, Universal Academy, sold unapproved devices in the U.S. by moving the products through fulfillment centers in Buffalo, N.Y, and Meriden, Conn. The two products, "Dr. Ho's Double Massage" and "Dr. Ho's Muscle Massage," were sold by Universal Academy in Markham, Ontario, and promoted as treatments for serious conditions including diabetic neuropathy, arthritis, migraines and multiple sclerosis, according to the DOJ.

Between August 2005 and January 2006, GRE Fulfillment in Buffalo received 200,000 of the products with an estimated retail value of more than $2.7 million, the DOJ said.

The units were assembled at GRE and transferred to Fosdick Fulfillment Corporation in Meriden, from which they were shipped to consumers throughout the U.S., the agency said.

U.S. Marshals, FDA officials and the State of Connecticut Department of Consumer Protection Drug Control Agents executed a warrant to seize an inventory of the devices valued at more than $1 million from Fosdick June 8, the DOG and FDA announced June 12. The GRE inventory has also been seized, the DOJ said.