Company · US
Invacare Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2021. Name variants (Inc, Corp, punctuation) are merged.
131510(k) clearances (0 in 12 months)
68recalls (0 in 12 months)
37recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ITI | Wheelchair, Powered | 63 |
| IOR | Wheelchair, Mechanical | 39 |
| CAW | Generator, Oxygen, Portable | 25 |
| FNL | Bed, Ac-Powered Adjustable Hospital | 9 |
| BXB | Exerciser, Powered | 8 |
| LLI | Bed, Therapeutic, Ac-Powered, Adjustable Home-Use | 8 |
| INI | Vehicle, Motorized 3-Wheeled | 6 |
| BZD | Ventilator, Non-Continuous (Respirator) | 5 |
| INO | Chair, Positioning, Electric | 5 |
| CAF | Nebulizer (Direct Patient Interface) | 4 |
| NFB | Conserver, Oxygen | 4 |
| ITJ | Walker, Mechanical | 3 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 |
| FMW | Cover, Mattress (Medical Purposes) | 2 |
| FSA | Lift, Patient, Non-Ac-Powered | 2 |
| INN | Chair, Adjustable, Mechanical | 2 |
| BYJ | Unit, Liquid-Oxygen, Portable | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 |
| DPS | Electrocardiograph | 1 |
| FNG | Lift, Patient, Ac-Powered | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 12, 2021 | K203210 | Invacare Platinum 5NXG Oxygen Concentrator Invacare Corporation | CAW |
| Mar 19, 2021 | K202379 | Invacare AVIVA Storm RX Power Chair Invacare Corporation | ITI |
| Aug 6, 2020 | K200890 | Invacare Perfecto2V Oxygen Concentrator Invacare Corporation | CAW |
| Jan 2, 2020 | K192216 | Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP Invacare Corporation | ITI |
| Aug 29, 2019 | K191159 | Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth D Invacare Corporation | CAW |
| Dec 11, 2018 | K182946 | Invacare TDX SP2-HD with Captain's Seat Invacare Corporation | ITI |
| Nov 14, 2018 | K181090 | Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs Invacare Corporation | IOR |
| Jul 12, 2017 | K170507 | Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System Invacare Corporation | ITI |
| Apr 17, 2017 | K162621 | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair Invacare Corporation | IOR |
| Dec 28, 2016 | K162696 | Kuschall Advance Manual Wheelchair Invacare Corporation | IOR |
| Dec 28, 2016 | K162692 | Kuschall K-Series Attract Manual Wheelchair Invacare Corporation | IOR |
| Dec 28, 2016 | K162686 | Kuschall Champion Manual Wheelchair Invacare Corporation | IOR |
| Sep 27, 2016 | K160630 | Invacare Platinum Mobile Oxygen Concentrator Invacare Corporation | CAW |
| Jan 5, 2016 | K152536 | MyOn HC Manual Wheelchair Invacare Corporation | IOR |
| Jan 9, 2015 | K141783 | TDX SP2 POWER WHEECHAIR Invacare Corporation | ITI |
| May 21, 2009 | K083751 | INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100 Invacare Corporation | CAW |
| Dec 12, 2007 | K071928 | THE INVACARE FLYER, MODEL IPC 100 Invacare Corp. | CAW |
| Nov 16, 2007 | K073134 | A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I Invacare Corporation | ITI |
| Apr 30, 2007 | K070321 | TWILIGHT FULL FACE MASK Invacare Corp. | BZD |
| Sep 21, 2006 | K062402 | EASYSTAND EVOLV Invacare Corp. | INO |
| Sep 5, 2006 | K061874 | INVACARE'S TWILIGHT II NASAL MASKS Invacare Corp. | BZD |
| Mar 16, 2006 | K060582 | INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR Invacare Corporation | IOR |
| Jan 6, 2005 | K042483 | INVACARE PRO, COMPACT AND PORTABLE DESKTOP Invacare Corporation | CAF |
| Jun 4, 2004 | K033819 | INVACARE 3G TARSYS Invacare Corp. | ITI |
| May 12, 2004 | K041072 | KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT Invacare Corporation | IOR |
| Mar 25, 2004 | K031176 | INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 Invacare Corp. | BTT |
| Mar 12, 2004 | K031064 | INVACARE POLARIS EX CPAP, MODEL ISP3000 Invacare Corp. | BZD |
| Mar 20, 2003 | K030814 | INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3 Invacare Corp. | INI |
| Feb 11, 2003 | K022642 | TWLIGHT, MODEL ISP 9600 Invacare Corp. | BZD |
| Nov 19, 2002 | K023589 | STORM TDX POWER WHEELCHAIR Invacare Corp. | ITI |
| Jul 23, 2002 | K021685 | VENTURE HOMEFILL II WITH OXYGEN CONSERVER Invacare Corp. | CAW |
| Jul 2, 2002 | K020386 | INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 Invacare Corp. | CAW |
| Jun 18, 2002 | K021680 | INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91 Invacare Corp. | ITI |
| Dec 13, 2001 | K013516 | INVACARE ELEVATING SEAT OPTION ESS6 Invacare Corp. | ITI |
| Oct 24, 2001 | K012909 | XTERRA GT POWER WHEELCHAIR Invacare Corp. | ITI |
| Sep 19, 2001 | K012927 | M71 POWER WHEELCHAIR Invacare Corp. | ITI |
| Aug 3, 2001 | K012370 | SOLARA JR. MANUAL WHEELCHAIR Invacare Corp. | IOR |
| Aug 1, 2001 | K012167 | MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR Invacare Corp. | IOR |
| Apr 17, 2001 | K003561 | INVACARE PASSOVER HUMIDIFIER MODEL ISP9700 Invacare Corp. | BTT |
| Mar 22, 2001 | K010364 | MCC-MIV ONE 2 ONE SOFTWARE Invacare Corp. | ITI |
| Mar 21, 2001 | K003939 | VENTURE HOME FILL II, MODEL IOH 200 Invacare Corp. | CAW |
| Feb 16, 2001 | K010135 | MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4 Invacare Corp. | INI |
| Oct 24, 2000 | K002284 | VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX Invacare Corp. | NFB |
| Aug 25, 2000 | K002317 | MODEL 9000 BARIATRIC WHEELCHAIR Invacare Corp. | IOR |
| Aug 25, 2000 | K002157 | RANGER II M6, MODEL IN-888WNL Invacare Corp. | ITI |
| Aug 10, 2000 | K002171 | INVACARE LIFT CHAIR Invacare Corp. | INO |
| Aug 4, 2000 | K002170 | MODEL 9000 PEDIATRIC WHEELCHAIR Invacare Corp. | IOR |
| Jul 24, 2000 | K001777 | MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS Invacare Corp. | ITI |
| Feb 18, 2000 | K000174 | ACTION AF-1 WHEELCHAIR Invacare Corp. | IOR |
| Dec 15, 1999 | K993413 | STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL Invacare Corp. | ITI |
Newest 50 of 131.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 4, 2024 | Invacare Corporation Invacare Homecare Series Bed and Invacare G-Series Beds Containing
Component Model Numbers:
(1) G50
(2) G53
(3) G54
(4) BAR5490IVC
(5) BAR5000IVC
(6) 5000IVC
(7) 5490IVC
(8) 5490LOW Open, Classified |
LLI | None listed |
| Aug 23, 2023 | Invacare Corporation DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat.
Model Number(s):
1654807 - DOLOMITE GLOSS 680 ROLLATOR
1655081 - DOLOMITE GLOSS 600 ROLLATOR
1655082 Open, Classified |
ITJ | None listed |
| Jun 10, 2022 | Invacare Corporation Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model) Open, Classified |
CAW | K203210 |
| 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 |
| Oct 30, 2020 | Invacare Corporation Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen
Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada),
All World: IRC5PO2VAW, IRC5 Terminated |
CAW | K200890 |
| Nov 16, 2018 | Invacare Corporation Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P
The intended use of a Non-AC-Powered patient lift is to lift and transfer a patient from one surface to another, as from a b Terminated |
FSA | None listed |
| Jun 1, 2017 | Invacare Corporation Assist Bed Rail - 6632 Terminated |
N/A | None listed |
| Dec 2, 2016 | Invacare Corporation Junction Box - 1104343 and 1193560 Terminated |
LLI | None listed |
| Dec 2, 2016 | Invacare Corporation Foot Section - BAR5490IVC Terminated |
LLI | None listed |
| Dec 2, 2016 | Invacare Corporation Bariatric Bed - BARPKG-IVC 1633 Terminated |
LLI | None listed |
| Dec 2, 2016 | Invacare Corporation Bariatric Bed - BAR600IVC Terminated |
LLI | None listed |
| Aug 8, 2016 | Invacare Corporation Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton.
The lnvacare Precise Rx" Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has Terminated |
NFB | K914488 |
| Aug 8, 2016 | Invacare Corporation lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton.
The lnvacare Precise Rx Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a sc Terminated |
NFB | K914488 |
| Mar 15, 2016 | Invacare Corporation Junction Boxes,
Product Usage:
The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours. Terminated |
FNL | None listed |
| Mar 15, 2016 | Invacare Corporation Invacare Foot Section for Semi & Full Electric Beds, Junction Boxes,
Product Usage:
The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and a Terminated |
FNL | None listed |
| Mar 15, 2016 | Invacare Corporation Invacare Bariatric Bed with mattress and rails , Junction Boxes,
Product Usage:
The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjus Terminated |
FNL | None listed |
| Mar 15, 2016 | Invacare Corporation Invacare Bariatric Bed w/o mattress & rails, Junction Boxes,
Product Usage:
The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustabl Terminated |
FNL | None listed |
| 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 |
| Feb 2, 2015 | Invacare Corporation G- Series Beds; G29 full length bed rails assembly Terminated |
FNL | None listed |
| Dec 24, 2014 | Invacare Corporation Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box. Terminated |
CAW | K020386 |
| Dec 12, 2014 | Invacare Corporation Invacare Perfecto 2 V Oxygen Concentrator
The finished device is packaged as a single unit.
The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished Terminated |
CAW | K020386 |
| Jul 22, 2014 | Invacare Corporation MK5 NX Controller--Wheelchair controller Terminated |
ITI | K021680 |
| Jul 9, 2014 | Invacare Corporation Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family. Terminated |
INN | None listed |
| Jan 8, 2014 | Invacare Corporation Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035
For transportation to accomplish necessary tasks of daily liv Terminated |
IOR | None listed |
| Nov 5, 2013 | Invacare Corporation Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet commode with tilting function.
Mobile shower and toilet commode with tilting function Terminated |
INN | None listed |
| 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 |
| Aug 17, 2013 | Invacare Corporation CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person.
Recliner provides heat and massage after surgery. Terminated |
INO | None listed |
| Feb 4, 2013 | Invacare Corporation Solara 3G Custom Manual Wheelchair
Product Usage: To provide mobility to a person restricted to a sitting position. Terminated |
IOR | K984447 |
| Dec 18, 2012 | Invacare Corporation Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged six (6) canes per shipping carton.
The cane is used as an aid in walking or ambulation. Terminated |
KHY | None listed |
| Sep 26, 2012 | Invacare Corporation Invacare I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035.
These shower chairs are designed for individuals who require seating support when bathing or showerin Terminated |
KMN | None listed |
| 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 |
| Jun 5, 2012 | Invacare Corporation Knee walker, one unit per box. Manufacturer Kenstone Metal (Kunshan) Co., LTD. The intended use is to provide additional mobility to individuals who have difficulty walking. Terminated |
ITJ | None listed |
| 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 |
| Jan 17, 2012 | Invacare Corporation Leo 3-Wheel Scooter and Leo Scooter, Distributed By:
Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035
Intended to provide transportation for a disabled or elderly person. Terminated |
INI | K090735 |
| Nov 14, 2011 | Invacare Corporation Invacare 600 lb. Bariatric Bed, Head motor extension cable used on component numbers BAR5490 and BAR5490IVC. These components are part of the following Bed Model Number(s): BAR600, BARPKGCA, BAR600I Terminated |
LLI | None listed |
| Sep 27, 2011 | Invacare Corporation Dual Blue-Release Adult Walkers - Wheeled, and Blue Release Junior Walkers with 5 inch Fixed Wheels, Model Numbers: 6240-5F and 6240-JR5F. The recalled product is packaged four (4) units per shipping Terminated |
ITJ | None listed |
| Jul 6, 2011 | Invacare Corporation JASMINE Full Body (Patient) Lift, electrically-powered device with a 500 lb. weight capacity.
The recalled product is an electrically-powered device either fixed or mobile, used to lift and transport Terminated |
FNG | None listed |
| Feb 24, 2011 | Invacare Corporation HomeFill Oxygen Compressor IOH200 Homefill, The serial numbers are as follows: 10JF034081, 10JF034082, 10JF034083, 10JF034084, 10JF034085, 10JF034086, 10JF034087, 10JF034088, 10JF034089, 10JF034090, 1 Terminated |
CAW | K003939 |
| Sep 12, 2010 | Invacare Corporation CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series of manual, semi-electric and electric beds.
Mattresses can be identified by looking on the law label tag for the fo Terminated |
FMW | None listed |
| Sep 12, 2010 | Invacare Corporation Mattress Model 5185 and 5185XL.
Manufactured by:
Invacare Corp., 2101 East Lake Mary Blvd., Sanford, FL 32773.
Mattress Model 5185 and 5185XL were packaged in the IVC Bed Models BED2-1633, BED4-16 Terminated |
FMW | None listed |
| Sep 9, 2010 | Invacare Corporation Invacare AC-Powered Adjustable Hospital Bed.
Model 5890 IVC and 5490 IVC.
Manufactured by:
Invacare Corp. 2101 East Lake Mary Blvd., Sanford, FL 32773. Terminated |
FNL | None listed |
| 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 |
| Nov 25, 2009 | Invacare Corporation Kuschall K Junior Manual wheelchair Terminated |
IOR | K982336 |
| 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 |
Newest 50 of 68.