Permobil AB
Medical device manufacturer in Lebanon, TN.
15510(k) clearances
0PMA approvals
8recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K190682 | Explorer MiniIPL · Traditional | 02/27/2020SE |
| K191874 | F5 Corpus VSIPL · Traditional | 10/25/2019SE |
| K143180 | F3ITI · Traditional | 03/27/2015SE |
| K143014 | F5ITI · Traditional | 03/25/2015SE |
| K123290 | M300 & M400ITI · Traditional | 04/17/2013SE |
| K103477 | Permobil M300 / M400ITI · Traditional | 03/03/2011SE |
| K081964 | K450 Powered WheelchairITI · Traditional | 07/29/2008SE |
| K071650 | C350 Powered WheelchairITI · Traditional | 09/12/2007SE |
| K041219 | ElectroITI · Traditional | 08/04/2004SE |
| K032765 | StreetITI · Traditional | 01/30/2004SE |
| K993406 | Trax, Powered Wheelchair, Model 308686-00-0ITI · Abbreviated | 12/18/2000SE |
| K991658 | Permobil Powered Wheelchair 1280ITI · Abbreviated | 10/08/1999SE |
| K960951 | Permobil Chairman L/Cs 8ITI · Traditional | 04/30/1997SE |
| K942508 | RoboINI · Traditional | 11/07/1994SN |
| K902954 | OBER2 Monitor, Eye Movement (Ophthalmic)HFC · Traditional | 08/23/1990SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2805-2026 Class II | M5 Corpus Power Wheelchair REF,120032This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit… | 06/19/2025Open, Classified |
| Z-2795-2026 Class II | Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031, Model version 3This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to… | 02/29/2024Open, Classified |
| Z-2005-2023 Class II | PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part…When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail… | 05/10/2023Open, Classified |
| Z-2004-2023 Class II | PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part…When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail… | 05/10/2023Open, Classified |
| Z-3178-2018 Class II | Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d)…This correction decision has been made because of a potential failure of one or both backrest bars providing… | 08/15/2018Terminated |
| Z-0006-2018 Class II | Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500There is a potential failure of the top plate assembly, which is the component that connects the seating… | 09/01/2017Terminated |
| Z-0005-2018 Class II | Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400…There is a potential failure of the top plate assembly, which is the component that connects the seating… | 09/01/2017Terminated |
| Z-1278-2012 | Permolock C3, Docking system for Power wheelchair in vehicle. Intended use: locking deviceThe fasteners used between June 3, 2011 and January 31, 2012 to attach the Permolock C3 pins to wheelchairs… | 02/21/2012Terminated |