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:
Registered with the Food and Drug Administration as a Biofeedback Class II medical device, Cat. Neurology since 2002.
(FDA’s Registration & Device Listing.)
The Ondamed is an approved physical therapy device by the Bahrain Health Ministry.
The Ondamed is an approved physical therapy device by the Medical Devices Bureau, Health Canada.
In November 2011, the Ondamed was approved by Health Canada for pain relief, treating wounds and soft tissue injuries. Licence #87618
The Ondamed was approved in China by SFDA in June 2009.
The Ondamed was approved in Korea by KFDA in July 2012.
In March 2012, the Saudi F.D.A. approved the Ondamed for pain relief, treating wounds and soft tissue injuries. Licence MDMA12110004
Approved by the Health Sciences Authority of Singapore: SDMR
License to import new electromedical devices – Licence Number: 933/14745
Approved by the Department of Health of Taiwan Taiwan Registration Permit