Company ยท SE
Permobil AB
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2020. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
8recalls (2 in 12 months)
8recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 27, 2020 | K190682 | Explorer Mini Permobil AB, SE | IPL |
| Oct 25, 2019 | K191874 | F5 Corpus VS Permobil AB, SE | IPL |
| Mar 27, 2015 | K143180 | F3 Permobil AB, SE | ITI |
| Mar 25, 2015 | K143014 | F5 Permobil AB, SE | ITI |
| Apr 17, 2013 | K123290 | M300 & M400 Permobil AB, SE | ITI |
| Mar 3, 2011 | K103477 | PERMOBIL M300 / M400 Permobil AB, SE | ITI |
| Jul 29, 2008 | K081964 | K450 POWERED WHEELCHAIR Permobil AB, SE | ITI |
| Sep 12, 2007 | K071650 | C350 POWERED WHEELCHAIR Permobil AB, SE | ITI |
| Aug 4, 2004 | K041219 | ELECTRO Permobil AB, SE | ITI |
| Jan 30, 2004 | K032765 | STREET Permobil AB, SE | ITI |
| Dec 18, 2000 | K993406 | TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0 Permobil AB, SE | ITI |
| Oct 8, 1999 | K991658 | PERMOBIL POWERED WHEELCHAIR 1280 Permobil AB, SE | ITI |
| Apr 30, 1997 | K960951 | PERMOBIL CHAIRMAN L/CS 8 Permobil AB, SE | ITI |
| Nov 7, 1994 | K942508 | ROBO Permobil AB, SE | INI |
| Aug 23, 1990 | K902954 | OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) Permobil AB | HFC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2026 | Permobil Inc Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock
REF:120031, Model version 3 Open, Classified |
ITI | K123290 |
| Jul 24, 2026 | Permobil Inc M5 Corpus Power Wheelchair REF,120032 Open, Classified |
ITI | K123290 |
| Jun 26, 2023 | Permobil PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable w Open, Classified |
ITI | K151199 |
| Jun 26, 2023 | Permobil PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable w Open, Classified |
ITI | K151199 |
| Aug 15, 2018 | Permobil, Ab Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d) C500 PS, (e) C400 PS
Product Usage:
The devices identified are intended to provide outdoor and indoor mobility Terminated |
ITI | K041219 K071650 +2 |
| Oct 3, 2017 | Permobil, Ab Electric Wheelchair bases:
a) C300
b) C350
c) C400
d) C500 Terminated |
ITI | K041219 K071650 +1 |
| Oct 3, 2017 | Permobil, Ab Electric Wheelchairs:
a) C300 CORPUS II
b) C350 CORPUS II
c) C400 CORPUS II
d) C400 CORPUS II LR
e) C500 CORPUS II
f) C500 CORPUS II LR Terminated |
ITI | K041219 K071650 +1 |
| Mar 22, 2012 | Permobil Inc Permolock C3, Docking system for Power wheelchair in vehicle.
Intended use: locking device Terminated |
KNN | K041219 |