The ONDAMED System – A Better Way To Make You Better
ONDAMED: A Breakthrough Technology for you and your patients.
Getting your “feet-back” to getting and staying well!
After more than 20 years of research and clinical use in Europe, North & South America, Asia and Australia , these advanced Class II-a medical technologies are approved in many countries for use by medical healthcare professionals and patients with their doctor’s prescription.
The brilliance lays in the personalization of treatment unique to each living being with the help of a Biofeedback method. This non-invasive therapeutic approach helps patients improve their stress tolerance. Stress is linked to most common disease. It is therefore critical to offer our patients relaxation training and improvement of attentiveness to their bodies, and their state of emotion.
Biofeedback sessions are covered by medicare, medicaid, and insurance companies. CPT codes are available upon request.
The U.S. FDA regulation states:
| Sec. 882.5050 Biofeedback device. |
(a) Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient’s physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to 882.9.
[44 FR 51730, Sept. 4, 1979, as amended at 63 FR 59229, Nov. 3, 1998]