The FDA responded to two separate 513(g) submissions for the Resonator, C030143 on October 28, 2003 and C040058 on May 14, 2004, stating that the Resonator could be marketed with the labeling, “to enhance feelings of relaxation,” without filing a premarket notification or submission with FDA. The FDA also stated in these responses that they did not intend to enforce premarket requirements for this device when marketed under this indication. The Office of Device Evaluation recently confirmed that this stance remains in effect at the present time.
The Resonator Model JR 18 was issued an EC Production Quality Assurance Certificate on August 1, 2001 for the therapeutic application for knee osteoarthritis; Certificate # 2001 01 0303 CP; NB # 0318.
The Resonator was issued a Health Canada Medical Device License on September 27, 2001; License Number 25852.
The Resonator™ device is an Investigational Device limited by Federal (or United States)
law to investigational use. The Resonator™ device is not for sale, nor is the
Magneceutical®
Therapy generally available outside of Investigational Review Board (IRB) approved clinical studies.
