Panels › Physical Medicine › Product code ITI · Class 2
Wheelchair, Powered
Regulation 890.3860
42510(k)s in 12 months (596 all time)
17recalls in 12 months (71 all time)
69recalls that name a 510(k)
Top companies in ITI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Quantum Rival
Model/Catalog Number: Quantum Rival
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Compone Open, Classified |
ITI | K011993 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: 4Front
Model/Catalog Number: 4Front
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Component: Controller Open, Classified |
ITI | K143383 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Quantum 4Front 2HD
Model/Catalog Number: Quantum 4Front 2HD
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.38 Open, Classified |
ITI | K143383 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Q6 Edge 4
Model/Catalog Number: Q6 Edge 4
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Component: Cont Open, Classified |
ITI | K143383 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Q6 Edge 3
Model/Catalog Number: Q6 Edge 3
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Component: Cont Open, Classified |
ITI | K143383 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Q6 Edge 2.0 (ilevel)
Model/Catalog Number: Q6 Edge 2.0 (ilevel)
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 89 Open, Classified |
ITI | K143383 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Quantum 1450
Model/Catalog Number: Quantum 1450
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Component Open, Classified |
ITI | K112815 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum rehab
Product Name: Q6 Edge 2.0
Model/Catalog Number: Q6 Edge 2.0
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Component: Open, Classified |
ITI | K042612 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Q6 Edge HD
Model/Catalog Number: Q6 Edge HD
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Component: Co Open, Classified |
ITI | K042612 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: R-TRAK
Model/Catalog Number: R-TRAK
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Component: Controller Open, Classified |
ITI | K011993 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Q6 Edge 3 Stretto
Model/Catalog Number: Q6 Edge 3 Stretto
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860 Open, Classified |
ITI | K143383 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Quantum Outback
Model/Catalog Number: Quantum Outback
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Com Open, Classified |
ITI | K112815 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Quantum 4Front 2
Model/Catalog Number: Quantum 4Front 2
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
C Open, Classified |
ITI | K143383 |
| 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 |
| Apr 24, 2026 | WHILL, INC. WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel
drive) powered wheelchair. Open, Classified |
ITI | K221438 |
| Apr 24, 2026 | WHILL, INC. WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair. Open, Classified |
ITI | K213383 |
| Sep 12, 2025 | Max Mobility LLC Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+
Wheelchair Power Assist component. Open, Classified |
ITI | K151199 |
| Sep 12, 2025 | Max Mobility LLC Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+
Wheelchair Power Assist component. Open, Classified |
ITI | K151199 |
| Sep 12, 2025 | Max Mobility LLC Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+
Wheelchair Power Assist component. Open, Classified |
ITI | K151199 |
| Feb 11, 2025 | Max Mobility LLC Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component. Open, Classified |
ITI | K151199 |
| Feb 11, 2025 | Max Mobility LLC Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component. Open, Classified |
ITI | K151199 |
| 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 |
| Mar 30, 2022 | Invacare Corporation Invacare TDX SP2, Model Nos. TDXSP2
TDXSP2-MCG
TDXSP2V Open, Classified |
ITI | K170507 |
| Nov 12, 2021 | Invacare Corporation Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A)
Models: SRX-20R, SRX-20SP, SRX-20MP Open, Classified |
ITI | K202379 |
| Nov 12, 2021 | Invacare Corporation Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A)
Models: IFX-20R, IFX-20SP, IFX-20MP, IFX-20C Open, Classified |
ITI | K192216 |
| Nov 12, 2021 | Invacare Corporation Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A)
Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, T Open, Classified |
ITI | K170507 |
| Apr 1, 2021 | Merits Holdings Co. dba Merits Health Products, Inc. Power Wheelchair Open, Classified |
ITI | K011513 K011687 +3 |
| May 11, 2020 | Sunrise Medical (US) LLC Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A Expandable (Item No.: 250ER10, Part No.: 123966). Terminated |
ITI | K142457 |
| 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 |
| Jan 3, 2017 | Pride Mobility Products Corp TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1).
Mobility Medical Device Terminated |
ITI | K041346 |
| Aug 10, 2015 | Invacare Corporation Invacare Pronto Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900. Terminated |
ITI | K021680 |
| Feb 20, 2015 | Invacare Corporation Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back Terminated |
ITI | K940051 |
| Feb 20, 2015 | Invacare Corporation FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back. Terminated |
ITI | K991168 |
| Feb 20, 2015 | Invacare Corporation TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back. Terminated |
ITI | K023589 |
| Sep 17, 2014 | Motion Concepts TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System. Terminated |
ITI | K023426 |
| Jul 22, 2014 | Invacare Corporation MK5 NX Controller--Wheelchair controller Terminated |
ITI | K021680 |
| Sep 23, 2013 | Invacare Corporation Invacare Power Wheelchair, one per box
To provide mobility to a person restricted to a sitting position. Terminated |
ITI | K023589 K993413 |
| Jun 29, 2012 | Invacare Corporation TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-H Terminated |
ITI | K023589 K991168 |
| Mar 12, 2012 | Invacare Corporation TDX SP Power Wheelchair, Model #'s: TDXSP-CG, TDXSP-CG-GT, TDXSP-MCG, TDXSP-MCG-GT, Distributed By:
Invacare Corporation, Elyria, OH 44035
The Invacare TDX power wheelchair is a battery powered, mot Terminated |
ITI | K023589 |
| Sep 29, 2010 | Pride Mobility Products Corp Jazzy Select 6 with XLR Port Harness Terminated |
ITI | K042612 |
| Sep 29, 2010 | Pride Mobility Products Corp Jazzy Select with XLR Port Harness Terminated |
ITI | K001970 |
| Dec 29, 2009 | Invacare Corporation Invacare Storm TDX SR Power Wheelchair with Stability Lock Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD Terminated |
ITI | K023589 |
| Jan 27, 2009 | Invacare Corporation Invacare Storm TDX SP Power Wheelchair with Stability Lock,
Model numbers: TDXSP, TDXSP-CG, and TDXSP-MCG
To provide mobility to a person restricted to a sitting position. Terminated |
ITI | K023589 |
| Sep 23, 2008 | Sunrise Medical Inc Sunrise Medical Quickie Groove Power Wheelchair with Transit option
The product is a powered wheelchair for human use. Terminated |
ITI | K060531 |
| Aug 27, 2008 | Pride Mobility Products Corp Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL, Q6000Z, R4000, Q600, Q600XL, Q610, Q1107, Q600E, and Dynamo 1107 Terminated |
ITI | K011993 K042612 +1 |
| Aug 23, 2008 | Sunrise Medical Inc Quickie Groove Power Wheelchair with QC (non-expandable) electronics, Model number EIPW13. Terminated |
ITI | K060531 |
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