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
In May 2008 Ondamed GmbH undergoes the ISO 13485 certification
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.
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.
The Ondamed companies are taking the needed steps to establish the ONDAMED® System with the regulatory authorities in identified markets. Our companies have undergone pre-clinical and clinical testing at various prestigious university hospitals and clinics in the U.S and in Europe.
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.
