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Article: Restorative Products, Tampa, FL, Dec. 2 (Florida).(MEDICAL DEVICES)
- Article from:
- Warning Letter Bulletin
- Article date:
- January 1, 2006
CopyrightCOPYRIGHT 2006 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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A June 28-July 1, 2005, investigation of Restorative Products elicited an extensive list of violations.
First, it was determined that the infrared lamps manufactured by the establishment were misbranded. The infrared lamps received clearance as electric heating pads on March 30, 1994, but on Oct. 19, 2001, FDA corrected this clearance and stated that the device "should have been classified as an infrared lamp rather than an electric heating pad."
The clearance letter, however, also stated the company could continue marketing the device as described in its 510(k). The 510(k) submission described the device as intended for relief of minor muscle and joint ...