Permobil, AB
Lebanon, TN, US
PERMOBIL AB appears in FDA device records in Lebanon, TN. FDA records list 18 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 15 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Permobil, AB carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Max Mobility, LLCregistration, 510(k), enforcement report, recall
- Permobile Inc.recall
510(k) clearance history
FDA records hold 18 510(k) clearances for Permobil, AB between 1990 and 2020. The busiest year on record is 2015, with 3. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1994 | 1 |
| 1997 | 1 |
| 1999 | 1 |
| 2000 | 1 |
| 2004 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2015 | 3 |
| 2019 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K190682 | Explorer Mini | IPL | Substantially Equivalent | |
| K191874 | F5 Corpus VS | IPL | Substantially Equivalent | |
| K151199 | SmartDrive Wheelchair Power Assist | ITI | Substantially Equivalent | |
| K143180 | F3 | ITI | Substantially Equivalent | |
| K143014 | F5 | ITI | Substantially Equivalent | |
| K123290 | M300 & M400 | ITI | Substantially Equivalent | |
| K113621 | SMARTDRIVE WHEELCHAIR POWER-ASSIST | ITI | Substantially Equivalent | |
| K103477 | PERMOBIL M300 / M400 | ITI | Substantially Equivalent | |
| K102837 | HIROLLER ELEVATING WHEELCHAIR | IPL | Substantially Equivalent | |
| K081964 | K450 POWERED WHEELCHAIR | ITI | Substantially Equivalent | |
| K071650 | C350 POWERED WHEELCHAIR | ITI | Substantially Equivalent | |
| K041219 | ELECTRO | ITI | Substantially Equivalent | |
| K032765 | STREET | ITI | Substantially Equivalent | |
| K993406 | TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0 | ITI | Substantially Equivalent | |
| K991658 | PERMOBIL POWERED WHEELCHAIR 1280 | ITI | Substantially Equivalent | |
| K960951 | PERMOBIL CHAIRMAN L/CS 8 | ITI | Substantially Equivalent | |
| K942508 | ROBO | INI | Substantially Equivalent for Some Indications | |
| K902954 | OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) | HFC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008370857 | 3008370857 | MAX MOBILITY, LLC | 300 DUKE DR, Lebanon, TN 37090 US | 2026 | |
| 8030931 | 3004908349 | PERMOBIL AB | Klokanvagen 16, Sundsvall Vasternorrland 86341 SE | 2026 | and 11 more, listed in full below |
| 1221084 | 1221084 | PERMOBIL, INC. | 300 Duke Dr, LEBANON, TN 37090 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNOAccessories, Wheelchair
- IMYArmboard, Wheelchair
- IMLArmrest, Wheelchair
- HFCAspirator, Endocervical
- IMQAttachment, Narrowing, Wheelchair
- IQBBelt, Wheelchair
- IMXBoard, Lap, Wheelchair
- IMWBrake, Extension, Wheelchair
- IMNClimber, Curb, Wheelchair
- KNNComponents, Wheelchair
- INCCuff, Pusher, Wheelchair
- IMPCushion, Wheelchair
- IMRDevice, Anti-Tip, Wheelchair
- IMMFootrest, Wheelchair
- IMOHandrim, Wheelchair
- INAHill Holder, Wheelchair
- IMZHolder, Crutch And Cane, Wheelchair
- OUGMedical Device Data System
- KIDRestraint, Wheelchair, Non-Protective
- IMSSupport, Head And Trunk, Wheelchair
- INIVehicle, Motorized 3-Wheeled
- IORWheelchair, Mechanical
- ITIWheelchair, Powered
- IPLWheelchair, Standup
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2540-2025 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component. | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries. | Class I | Open, Classified | |
| Z-2539-2025 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component. | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries. | Class I | Open, Classified | |
| Z-2538-2025 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component. | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries. | Class I | Open, Classified | |
| Z-2805-2026 | M5 Corpus Power Wheelchair REF,120032 | This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive under restricted conditions, and may create an unstable condition in certain circumstances. | Class II | Open, Classified | |
| Z-1117-2025 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component. | Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries. | Class I | Open, Classified | |
| Z-1116-2025 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component. | Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries. | Class I | Open, Classified | |
| Z-2795-2026 | Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031, Model version 3 | This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to maintain stability when the seat lift exceeds 50 mm, which may cause the user to fall from the wheelchair or the wheelchair to tip over, | Class II | Open, Classified | |
| Z-2005-2023 | 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 watch that communicates with a SmartDrive Power Assist Device via the SmartDrive MX2+ Application | When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail unexpectedly. If this happens, the motor on the power assist device continues to run and the user may not be able to stop the device using tap gestures. | Class II | Open, Classified | |
| Z-2004-2023 | 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 watch that communicates with a SmartDrive Power Assist Device via the SmartDrive MX2+ Application | When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail unexpectedly. If this happens, the motor on the power assist device continues to run and the user may not be able to stop the device using tap gestures. | Class II | Open, Classified | |
| Z-3178-2018 | 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 to persons limited to a seated position that can operate a powered wheelchair. | This correction decision has been made because of a potential failure of one or both backrest bars providing back support. If one or both back support telescoping bars fail the user could fall back leading to a potential injury. | Class II | Terminated | |
| Z-0006-2018 | Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500 | There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base. | Class II | Terminated | |
| Z-0005-2018 | 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 | There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base. | Class II | Terminated | |
| Z-1278-2012 | Permolock C3, Docking system for Power wheelchair in vehicle. Intended use: locking device | The fasteners used between June 3, 2011 and January 31, 2012 to attach the Permolock C3 pins to wheelchairs manufactured in the United States do not contain the required nylon ring, which allows for a more secure attachment. | Terminated | ||
| Z-0834-03 | Permobil Chairman 2K powered wheelchair | One of the wheelchair motors needed a grounding strap to ensure that the motors are at the same voltage potential as the chassis of the wheelchair. | Terminated | ||
| Z-0671-03 | Permobil Chairman 2K powered wheelchair, Model 1280 | Incidents were reported where a drive wheel has come off its motor axle, due either to loosening of the wheel bolt or a broken wheel bolt. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain