Medical device licence · 76749 · Class 2
ALTERNATING PRESSURE SUPPORT SURFACES
Yes: licensed in Canada
Licence status Issued (active); first licensed April 2, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76749
- Licence holder
- Wellell Inc.New Taipei City, Taiwan
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- April 2, 2008
- Devices covered
- 22
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACS LAL AIR PUMP AND MATTRESS SYSTEM
- ACS TURN AIR PUMP AND MATTRESS SYSTEM
- AIR JUNIOR AIR PUMP AND CUSHION SYSTEM
- DOMUS 1
- DOMUS 2S
- DOMUS 3
- DOMUS 4
- DOMUS AUTO
- EXCEL 1000/2000/5000/8000 ALTERNATING PRESSURE RELIEF SYSTEM
- OPTIMA AUTO
- OPTIMA PRONE
- OPTIMA TURN
- PM170 AIR PUMP AND MATTRESS SYSTEM
- PM211 AIR PUMP AND MATTRESS SYSTEM
- PM211AA DYNAMIC ALTERNATING THERAPY PUMP REPLACEMENT MATTRESS SYSTEM
- PROCARE AUTO G2
- PROCARE BARIATRIC G2
- PROCARE ELITE
- SEDENS 500
- SERENE AIR
- SERENE LOW AIR LOSS WITH ALTERNATING PRESSURE SYSTEM
- VERSO
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.