Medical device licence · 96043 · Class 2
BTL-6000 TR-THERAPY
Yes: licensed in Canada
Licence status Issued (active); first licensed November 5, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 96043
- Licence holder
- Btl Industries LimitedStevenage, HT, United Kingdom
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 5, 2015
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BTL-6000 TR-THERAPY ELITE
- BTL-6000 TR-THERAPY PRO
- CAPACITIVE APPLICATOR
- CAPACTIVE ELECTRODE
- ELECTROSURGICAL DISPOSABLE GROUND PAD
- NEUTRAL ELECTRODE
- PATIENT CABLE FOR CAPACITIVE ELECTRODES
- PATIENT CABLE FOR NEUTRAL ELECTRODE
- PATIENT CABLE FOR RESISTIVE ELECTRODES
- PATIENT CABLE FOR STATIC APPLICATION
- RESISTIVE APPLICATOR
- RESISTIVE ELECTRODE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.