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:
    • IEC 60601-1:1988 + A1:1991 + A2:1995; EN 60601-1:1990 and
    • DIN EN 60601-1:1996
  • ISO 13485 certification

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.

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ASIA:

 

 

AFRICA:

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

 

 

AUSTRALIA:

 

 

 

CANADA

  • The ONDAMED System is an approved physical therapy device by the Medical Devices Bureau, Health Canada.
  • The ONDAMED System has been approved in Canada November 2011. Licence #87618.

 

 

ITALY