Permobil, Ab

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
15
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2004-2023Class IIPushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-3May 10, 2023
Z-2005-2023Class IIPushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-3May 10, 2023
Z-3178-2018Class IIPermobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d) C500 PS, (eAugust 15, 2018
Z-0006-2018Class IIElectric Wheelchair bases: a) C300 b) C350 c) C400 d) C500September 1, 2017
Z-0005-2018Class IIElectric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LRSeptember 1, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K190682Explorer MiniFebruary 27, 2020
K191874F5 Corpus VSOctober 25, 2019
K143180F3March 27, 2015
K143014F5March 25, 2015
K123290M300 & M400April 17, 2013
K103477PERMOBIL M300 / M400March 3, 2011
K081964K450 POWERED WHEELCHAIRJuly 29, 2008
K071650C350 POWERED WHEELCHAIRSeptember 12, 2007
K041219ELECTROAugust 4, 2004
K032765STREETJanuary 30, 2004
K993406TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0December 18, 2000
K991658PERMOBIL POWERED WHEELCHAIR 1280October 8, 1999
K960951PERMOBIL CHAIRMAN L/CS 8April 30, 1997
K942508ROBONovember 7, 1994
K902954OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)August 23, 1990