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Certifications

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

U.S.A.:

• 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:

• The ONDAMED® System is an approved physical therapy device by the Bahrein health ministry.
• The ONDAMED® System is currently undergoing approval by the SFDA in China as well as the KFDA in Korea.

Our mission is to educate medical professionals with scientific facts that are researched and published by leading scientists. Ondamed believes in truth and ethics and delivers these essential ingredients within its products and within the people that are part of the Ondamed teams worldwide.