Medical device licence · 98843 · Class 2
BITS (BIONESS INTEGRATED THERAPY SYSTEM)
Yes: licensed in Canada
Licence status Issued (active); first licensed March 22, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98843
- Licence holder
- Bioness Inc.Valencia, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- March 22, 2017
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BITS (BIONESS INTEGRATED THERAPY SYSTEM)
- BITS COMPUTER KIT
- BITS HARDWARE KIT
- BITS SOFTWARE KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.