ApprovalTrail

Medical device licence · 13140 · Class 2

TENS MACHINE

No longer licensed: cancelled: quality-system requirement (2003)

Licence status Cancelled: quality-system requirement (2003); first licensed October 20, 1999; ended February 16, 2004. It is in Health Canada’s archive of licences no longer in force.
Licence number
13140
Licence holder
American ImexIrvine, CA, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
October 20, 1999
Ended
February 16, 2004
Devices covered
10

Devices on this licence

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

  • A-TENS
  • BIOTENS
  • EASY TENS
  • MICROCARE II
  • PAIN CARE TENS
  • PREMIER AP
  • PREMIER TENS
  • SDIII
  • SDIIP
  • STANDARD TENS

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