Jolife AB
Medical device manufacturer in Lund, Swed.
5510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K173553 | LUCAS 3 Chest Compression SystemDRM · Traditional | 02/08/2018SE |
| K161768 | LUCAS 3 Chest Compression SystemDRM · Traditional | 11/09/2016SE |
| K090422 | Lucas 2DRM · Traditional | 06/17/2009SE |
| K062401 | Modification to LucasDRM · Traditional | 09/28/2006SE |
| K053403 | LucasDRM · Traditional | 02/01/2006SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2161-2026 Class II | LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code:…Due to a subset of chest compression systems/devices where the service performed on the systems were not… | 04/13/2026Open, Classified |
| Z-1998-2025 Class II | LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external…Due to demonstration units of chest compression system being provided to a customer which may potentially be… | 05/21/2025Open, Classified |
| Z-1664-2011 | LUCAS 2 Chest Compression System. The device's Instruction for Use is labeled in part:…LUCAS 2 Chest Compression System may have malfunctions resulting from the failure of a hood probe on the… | 02/08/2011Terminated |