The ONDAMED® System is CE certified as a Class II Medical Therapy Device. The Medical Device Certification GMBH audit has proven, that this quality system meets all requirements according to Annex VI – Section 3 of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
In addition, ONDAMED® has been approved for use under the supervision of AAABEM, an Institutional Review Board, as safe for research or clinical testing as a non-invasive secondary therapeutic device in the treatment of pain, discomfort, or general malaise.
Biofeedback devices are exempt from 510(k) pre-market notification (882.5050).
In 2002, the F.D.A. accepted the ONDAMED System as a biofeedback device, Class II, in the Category Neurology.
In 2003, the F.D.A. requested that ONDAMED include a battery, in order to meet the F.D.A. guidelines set forth for biofeedback devices.
The device was put on the import alert list until a battery is implemented. Several months later, the device was re-engineered to fit a battery.
All devices shipped worldwide can now be battery operated to help in remote areas where electricity may not be available. The Ondamed companies and the ONDAMED System have been re-registered with the F.D.A. since the battery insertion and are in compliance; however, F.D.A.'s import alert list is not updated since it is their policy to keep a record of all alerts (whether they are timely or not) . Proper registration and fees are required by the F.D.A. every year, which are fulfilled by the Ondamed companies.
