FDA WARNING_LETTER - Revecomed International Inc - September 05, 2012

This FDA Warning Letter, dated March 1, 2013, addresses RevecoMED International, Inc. following an inspection from August 23 to September 5, 2012, regarding their LipoTRON 3000 device. The FDA determined that while the firm markets the device as a therapeutic massager (Class I, exempt from premarket notification under 21 CFR 890.5660), the LipoTRON 3000 delivers heat via radio frequency energy, exceeding the exemption limitations in 21 CFR 890.9. Consequently, the device is adulterated under section 501(f)(1)(B) of the Act due to the lack of an approved premarket approval (PMA) or investigational device exemption. It is also misbranded under section 502(o) of the Act for failure to submit a 510(k) premarket notification. Furthermore, the firm approved distributor marketing materials for the Lipo-Ex program, which includes the LipoTRON 3000, making unapproved claims such as fat reduction, comparisons to surgical procedures, and specific physiological effects (e.g., vasodilation, increased blood profusion), for which approval or clearance is required. RevecoMED must take prompt corrective actions and respond in writing within fifteen business days, detailing steps taken, prevention plans, and a timetable for completion, to avoid potential regulatory actions including seizure, injunction, and civil money penalties.