USA

  • Registered with the Food and Drug Administration as a Biofeedback Class II medical device, Cat. Neurology. Since 2002

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

  • EC Certificate "Medical Device using pulsed electromagnetic fields for tissue stimulation"

  • ISO 13485 certification

  • DQS Certificate

  • Italian Medical Device Registration - January 2012

  • UE 93/42/EWG - Poland

           Certificates


ARGENTINA

AUSTRALIA

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.

  • In November of 2011, the ONDAMED System was approved by Health Canada for pain relief, treating wounds and soft tissue injuries. Licence #87618

CHINA

KOREA

 SAUDI ARABIA 

  • In March 2012, the ONDAMED System was approved by the Saudi F.D.A. 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

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