Medical device licence · 77829 · Class 2
ACAPELLA
Yes: licensed in Canada
Licence status Issued (active); first licensed August 22, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 77829
- Licence holder
- Icu Medical Inc.Dublin, OH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- August 22, 2008
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACAPELLA CHOICE BLUE VIBRATORY PEP DEVICE
- ACAPELLA CHOICE VIBRATORY PEP
- ACAPELLA DUET AUTOCLAVABLE PEP DEVICE
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “acapella”. A notice may cover another product or only some lots: read it to see what it covers.
- Portex Acapella DH (Green) Vibratory PEP Device with Mouthpiece (2020-12-18)January 7, 2021 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.