ApprovalTrail

Medical device licence · 66364 · Class 2

TENS ELECTROTHERAPY STIMULATORS

Yes: licensed in Canada

Licence status Issued (active); first licensed November 5, 2004. It is in Health Canada’s list of active licences.
Licence number
66364
Licence holder
Djo France SasMouguerre, France
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
November 5, 2004
Devices covered
18

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • ACUS 4
  • BASIX 3 STIMULATOR
  • CEFAR BASIC
  • CEFAR EASY, STIMULATOR
  • CEFAR IFC
  • CEFAR PRIMO PRO
  • EMPI ECLIPSE+ DIGITAL
  • ENERGY II
  • MI FITNESS STIMULATOR
  • PAINMATCHER
  • PRIMO EASY STIMULATOR
  • PRIMO STIMULATOR
  • RUNNER
  • RUNNER MULTI
  • RUNNER MULTI + SENSOR
  • RUNNER STIMULATOR
  • RUNNER UK
  • TEMPO STIMULATOR

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.