Medical device licence · 99428 · Class 2
L300 GO
Yes: licensed in Canada
Licence status Issued (active); first licensed July 18, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99428
- Licence holder
- Bioness Inc.Valencia, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 18, 2017
- Devices covered
- 20
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BLUETOOTH DONGLE
- CENTRAL EPG
- CLOTH ELECTRODE BASE
- HYDROGEL ELECTRODE
- L300 GO CLINICIAN PROGRAMMER
- L300 GO FITTING CABLE
- L300 GO SYSTEM
- L300 GO, CENTRAL EPG
- L300 GO, FOOT SENSOR
- L300 GO, MYBIONESS MOBILE APPLICATION
- L300 GO, PERIPHERAL EPG
- L300 GO, REMOTE CONTROL
- MAGNETIC CHARGING CORD
- PERIPHERAL EPG
- QUICK FIT ELECTRODE
- ROUND CLOTH ELECTRODES
- SMALL ELECTRODE SET
- STEERING CLOTH ELECTRODE
- THIGH CLOTH ELECTRODE
- UNIVERSAL OUTLET WITH ADAPTERS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.