Medical device licence · 60428 · Class 4
ORION-1 EMF SYSTEM
No longer licensed: cancelled: quality-system requirement (2003)
Licence status Cancelled: quality-system requirement (2003); first licensed September 9, 2002; ended March 4, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 60428
- Licence holder
- Ortho Development CorporationDraper, UT, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- September 9, 2002
- Ended
- March 4, 2004
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ORION-1 EMF SYSTEM - ELECTRODES
- ORION-1 EMF SYSTEM - EXTENSION CABLES
- ORION-1 EMF SYSTEM - HANDPIECE ASSEMBLY
- ORION-1 EMF SYSTEM - MAIN DEVICE SET
- ORION-1 EMF SYSTEM - POWER CORD
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.