Medical device licence · 87827 · Class 2
NESS L300 PLUS SYSTEM
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed December 12, 2011; ended December 11, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 87827
- Licence holder
- Bioness Neuromodulation Ltd.Hod Hasharon, Israel
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 12, 2011
- Ended
- December 11, 2019
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AUDICOR TS SYSTEM - AUDICOR 200 CONSOLE, MEDICAL GRADE POWER SUPPLY
- L300 PLUS CLINICIAN'S PACK W/SOFTWARE
- L300 PLUS CONTROL UNIT
- L300 PLUS SYSTEM CHARGER
- L300 PLUS W CABLE
- NESS L300 PLUS - CLINICIAN KIT UPGRADE
- NESS L300 PLUS - SYSTEM KIT
- NESS L300 PLUS - UPGRADE KIT
- THIGH FS CUFF
- THIGH RF STIM UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.