ApprovalTrail

Medical device licence · 105760 · Class 3

SOFWAVE

Yes: licensed in Canada

Licence status Issued (active); first licensed January 25, 2021. It is in Health Canada’s list of active licences.
Licence number
105760
Licence holder
Sofwave Medical Ltd.Yokneam Illit, Israel
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
January 25, 2021
Devices covered
10

Devices on this licence

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

  • PURE IMPACT
  • PURE IMPACT ELECTRODE PADS
  • PURE IMPACT STIMULATION MODULES CHARGING STATION
  • PURE IMPACT WIRELESS STIMULATION MODULE
  • SOFWAVE
  • SOFWAVE FOOTSWITCH
  • SOFWAVE LIFT APPLICATOR
  • SOFWAVE LIFTHD APPLICATOR
  • SOFWAVE POWER CABLE
  • SOFWAVE PRECISE APPLICATOR

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