Certifications

The ONDAMED SYSTEM is approved by a growing number of government authorities worldwide, offering its therapeutic benefits to physicians and patients all around the world.

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

 

EUROPE

  • 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
  • The ONDAMED® System is certified in the additional following norms:

USA

  • Registered with the Food and Drug Administration as a Biofeedback Class II medical device, Cat. Neurology.
  • 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.

  • + more info

             ARGENTINA

             

            AUSTRALIA

             

            BAHRAIN

            • The ONDAMED System is an approved physical therapy device by the Bahrain health ministry

             

            CANADA

            • The ONDAMED System is an approved physical therapy device by the Medical Devices Bureau, Health Canada.
            • In November of 2011, the ONDAMED System was approved by Health Canada for pain relief, treating wounds and soft tissue injuries. Licence #87618.

             

            CHINA

            ITALY

             

            KOREA

             

            SAUDI ARABIA

            • In March 2012, the ONDAMED System was approved by the Saudi F.D.A. for pain relief, treating wounds and soft tissue injuries. Licence MDMA12110004

             

            SINGAPORE

            • Approved by the Health Sciences Authority of Singapore: SDMR

             

            SOUTH AFRICA

            • License to import new electromedical devices - Licence Number: 933/14745