FDA WARNING_LETTER - Curatronic Ltd. - December 19, 2012

On January 9, 2013, the FDA issued a Warning Letter to Curatronic Ltd. for marketing several Pulsed Electro-Magnetic Field Therapy (PEMF) devices, including BioMove 3000, BioMove 5000, Curatron 2000 HT, Curatron 2000 XP, Curatron 2000PC, and Curatron Ultra-Power 3-D PEMF, in the U.S. without proper marketing clearance or approval. The FDA's Office of Compliance reviewed the firm's websites and found that BioMove devices, though having 510(k) clearance for specific indications, were promoted for uncleared uses such as spinal cord injury and cerebral palsy rehabilitation, and for teaching the brain to re-develop, which constitute new intended uses requiring a new 510(k) submission per 21 CFR 807.81(a)(3). Additionally, unsubstantiated comparative claims were made. The Curatron PEMF devices were marketed without any clearance or approval, despite being classified as Class III devices requiring PMA approval. Consequently, all listed devices are deemed adulterated under section 501(f)(1)(B) of the Act due to the lack of an approved PMA or investigational device exemption, and misbranded under section 502(o) for failure to submit required 510(k) notifications. Curatronic Ltd. is required to immediately cease dissemination of violative promotional materials and distribution of the Curatron devices. The firm must respond within fifteen business days detailing corrective actions, a prevention plan, and a timetable for completion, to avoid further regulatory action including device detention.