Certifications
 

ONDAMED; Focused Tissue Stimulation And Biofeedback approved by various global health authorities for treatment of pain, soft tissue injuries & wounds.

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

 


USA

  • Registered with the Food and Drug Administration as a Biofeedback Class II medical device, Cat. Neurology. since 2002
    Please click here to view the: FDA's Registration & Device Listing.

 


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