FDAnews Device Daily Bulletin

Device Claims on Website Attract Warning Letter

Oct. 12, 2009
Marketing claims on Netproductstore’s websites for the Rhythm Touch Q 2-Way go beyond the indications the device was cleared for, according to a Sept. 11 warning letter recently posted to the FDA website. CDRH’s Office of Compliance, which reviewed the websites Sept. 2, requests that the California distributor immediately stop marketing the electronic muscle stimulator for such unapproved uses as the treatment of anemia, peripheral nerve palsy, fibromyalgia, multiple sclerosis and diabetes. Bud Meachum, the owner of Netproductstore, said he had not received the warning letter and was unaware of any concerns about the marketing of the product.
Devices & Diagnostics Letter