Medical device licence · 78553 · Class 2
EMG ELECTRODES
Yes: licensed in Canada
Licence status Issued (active); first licensed November 28, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 78553
- Licence holder
- Medtronic Xomed Inc.Jacksonville, FL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- November 28, 2008
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EMG HOOKWIRE ELECTRODES, PAIRED ELECTRODES
- EMG HOOKWIRE ELECTRODES, SINGLE ELECTRODES
- PAIRED SUBDERMAL ELECTRODE (8 CHANNEL)
- PAIRED SUBDERMAL ELECTRODE, 2-CHANNEL
- PAIRED SUBDERMAL ELECTRODE, 4-CHANNEL
- PAIRED SUBDERMAL ELECTRODE, MULTI-CHANNEL
- PRASS PAIRED ELECTRODES WITH SMALL HUB (2 CHANNEL)
- PRASS PAIRED ELECTRODES WITH SMALL HUB (4 CHANNEL)
- PRASS PAIRED EMG ELECTRODE, 2-CHANNEL
- PRASS PAIRED EMG ELECTRODE, 4-CHANNEL
- SUBDERMAL NEEDLE TWISTED PAIR ELECTRODES (4 CHANNEL)
- SUBDERMAL NEEDLE TWISTED PAIR ELECTRODES (8 CHANNEL)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.