ONDAMED; Focused Tissue Stimulation And Biofeedback approved by various global health authorities for treatment of pain, soft tissue injuries & wounds.
- 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
- 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.
- The ONDAMED System is an approved physical therapy device by the Bahrain health ministry
- 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
- The ONDAMED System has been approved in Korea by KFDA in July 2012
- 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
- 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