Ondamed Registration and Certifications

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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

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.

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

AUSTRALIA

•    ARTG Certificate

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.
•    The ONDAMED System has been approved in Canada November 2011. Licence #87618.

CHINA
•    The ONDAMED System has been approved in China by SFDA in June 2009

ITALY
•    Italian Medical Device Registration – January 2012

KOREA
•    The ONDAMED System has been approved in Korea by KFDA in July 2012

SAUDI ARABIA
•    Approved in the Kingdom of Saudi Arabia March 2012 MDMA12110004

SOUTH AFRICA
•    License to import new electromedical devices – Licence Number: 933/14745

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