Medical device licence · 101896 · Class 2
PONS PORTABLE NEUROMODULATION STIMULATOR
Yes: licensed in Canada
Licence status Issued (active); first licensed October 17, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101896
- Licence holder
- Helius Medical, Inc.Newtown, PA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 17, 2018
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PONS MOUTHPIECE
- PONS STARTER KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.