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:
- The ONDAMED System is an approved physical therapy device by the Bahrain health ministry.
- The ONDAMED System has been approved in Korea by KFDA in May 2009.
- The ONDAMED System has been approved in China by SFDA in June 2009.