ONDAMED Certification

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:

USA

Registered with the Food and Drug Administration as a Biofeedback Class II medical device, Cat. Neurology since 2002. 
(FDA’s Registration & Device Listing.)

ARGENTINA

ARTG Certificate

AUSTRALIA

ARTG Certificate

BAHRAIN

The Ondamed is an approved physical therapy device by the Bahrain Health Ministry.

 CANADA

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

CHINA

The Ondamed was approved in China by SFDA in June 2009.

KOREA

The Ondamed was approved in Korea by KFDA in July 2012.

SAUDI ARABIA

In March 2012, the Saudi F.D.A. approved the Ondamed for pain relief, treating wounds and soft tissue injuries. Licence MDMA12110004

SINGAPORE

Approved by the Health Sciences Authority of Singapore: SDMR

SOUTH AFRICA

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

TAIWAN

Approved by the Department of Health of Taiwan Taiwan Registration Permit