Invacare GmbH
Elyria, OH, US
Invacare GmbH appears in FDA device records in Elyria, OH. FDA records list 131 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 68 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Invacare GmbH 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.
- INVACARE CORP. DBA INVACARE AMERICAregistration
510(k) clearance history
Showing 50 of 131FDA records hold 131 510(k) clearances for Invacare GmbH between 1980 and 2021. The busiest year on record is 1985, with 12. The most recent is 2021, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1984 | 3 |
| 1985 | 12 |
| 1986 | 5 |
| 1987 | 4 |
| 1988 | 12 |
| 1989 | 5 |
| 1990 | 5 |
| 1991 | 1 |
| 1992 | 6 |
| 1993 | 3 |
| 1994 | 5 |
| 1995 | 4 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 4 |
| 1999 | 10 |
| 2000 | 7 |
| 2001 | 9 |
| 2002 | 4 |
| 2003 | 2 |
| 2004 | 4 |
| 2005 | 1 |
| 2006 | 3 |
| 2007 | 3 |
| 2009 | 1 |
| 2015 | 1 |
| 2016 | 5 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K203210 | Invacare Platinum 5NXG Oxygen Concentrator | CAW | Substantially Equivalent | |
| K202379 | Invacare AVIVA Storm RX Power Chair | ITI | Substantially Equivalent | |
| K200890 | Invacare Perfecto2V Oxygen Concentrator | CAW | Substantially Equivalent | |
| K192216 | Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP | ITI | Substantially Equivalent | |
| K191159 | Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity | CAW | Substantially Equivalent | |
| K182946 | Invacare TDX SP2-HD with Captain's Seat | ITI | Substantially Equivalent | |
| K181090 | Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs | IOR | Substantially Equivalent | |
| K170507 | Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx | ITI | Substantially Equivalent | |
| K162621 | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair | IOR | Substantially Equivalent | |
| K162696 | Kuschall Advance Manual Wheelchair | IOR | Substantially Equivalent | |
| K162692 | Kuschall K-Series Attract Manual Wheelchair | IOR | Substantially Equivalent | |
| K162686 | Kuschall Champion Manual Wheelchair | IOR | Substantially Equivalent | |
| K160630 | Invacare Platinum Mobile Oxygen Concentrator | CAW | Substantially Equivalent | |
| K152536 | MyOn HC Manual Wheelchair | IOR | Substantially Equivalent | |
| K141783 | TDX SP2 POWER WHEECHAIR | ITI | Substantially Equivalent | |
| K083751 | INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100 | CAW | Substantially Equivalent | |
| K071928 | THE INVACARE FLYER, MODEL IPC 100 | CAW | Substantially Equivalent | |
| K073134 | A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I | ITI | Substantially Equivalent | |
| K070321 | TWILIGHT FULL FACE MASK | BZD | Substantially Equivalent | |
| K062402 | EASYSTAND EVOLV | INO | Substantially Equivalent | |
| K061874 | INVACARE'S TWILIGHT II NASAL MASKS | BZD | Substantially Equivalent | |
| K060582 | INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR | IOR | Substantially Equivalent | |
| K042483 | INVACARE PRO, COMPACT AND PORTABLE DESKTOP | CAF | Substantially Equivalent | |
| K033819 | INVACARE 3G TARSYS | ITI | Substantially Equivalent | |
| K041072 | KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT | IOR | Substantially Equivalent | |
| K031176 | INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 | BTT | Substantially Equivalent | |
| K031064 | INVACARE POLARIS EX CPAP, MODEL ISP3000 | BZD | Substantially Equivalent | |
| K030814 | INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3 | INI | Substantially Equivalent | |
| K022642 | TWLIGHT, MODEL ISP 9600 | BZD | Substantially Equivalent | |
| K023589 | STORM TDX POWER WHEELCHAIR | ITI | Substantially Equivalent | |
| K021685 | VENTURE HOMEFILL II WITH OXYGEN CONSERVER | CAW | Substantially Equivalent | |
| K020386 | INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 | CAW | Substantially Equivalent | |
| K021680 | INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91 | ITI | Substantially Equivalent | |
| K013516 | INVACARE ELEVATING SEAT OPTION ESS6 | ITI | Substantially Equivalent | |
| K012909 | XTERRA GT POWER WHEELCHAIR | ITI | Substantially Equivalent | |
| K012927 | M71 POWER WHEELCHAIR | ITI | Substantially Equivalent | |
| K012370 | SOLARA JR. MANUAL WHEELCHAIR | IOR | Substantially Equivalent | |
| K012167 | MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR | IOR | Substantially Equivalent | |
| K003561 | INVACARE PASSOVER HUMIDIFIER MODEL ISP9700 | BTT | Substantially Equivalent | |
| K010364 | MCC-MIV ONE 2 ONE SOFTWARE | ITI | Substantially Equivalent | |
| K003939 | VENTURE HOME FILL II, MODEL IOH 200 | CAW | Substantially Equivalent | |
| K010135 | MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4 | INI | Substantially Equivalent | |
| K002284 | VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX | NFB | Substantially Equivalent | |
| K002317 | MODEL 9000 BARIATRIC WHEELCHAIR | IOR | Substantially Equivalent | |
| K002157 | RANGER II M6, MODEL IN-888WNL | ITI | Substantially Equivalent | |
| K002171 | INVACARE LIFT CHAIR | INO | Substantially Equivalent | |
| K002170 | MODEL 9000 PEDIATRIC WHEELCHAIR | IOR | Substantially Equivalent | |
| K001777 | MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS | ITI | Substantially Equivalent | |
| K000174 | ACTION AF-1 WHEELCHAIR | IOR | Substantially Equivalent | |
| K993413 | STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL | ITI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1531186 | 3002889431 | INVACARE CORP. DBA INVACARE AMERICA | ONE INVACARE WAY, ELYRIA, OH 44035 US | 2026 | and 21 more, listed in full below |
| 3007231105 | 3007231105 | Invacare GmbH | Am Achener Hof 8, Isny Baden-Wurttemberg 88316 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNOAccessories, Wheelchair
- ILSAdaptor, Hygiene
- QTCAdult Portable Bed Rails For Medical Purposes
- IKXAid, Transfer
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- IMLArmrest, Wheelchair
- OSIBariatric Bed
- FNLBed, Ac-Powered Adjustable Hospital
- IKZBed, Patient Rotation, Powered
- LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use
- IQBBelt, Wheelchair
- IMXBoard, Lap, Wheelchair
- IMWBrake, Extension, Wheelchair
- INOChair, Positioning, Electric
- INMChair, With Casters
- IMNClimber, Curb, Wheelchair
- KNNComponents, Wheelchair
- NFBConserver, Oxygen
- FMWCover, Mattress (Medical Purposes)
- IMPCushion, Wheelchair
- IMRDevice, Anti-Tip, Wheelchair
- DPSElectrocardiograph
- BXBExerciser, Powered
- IMMFootrest, Wheelchair
- CAWGenerator, Oxygen, Portable
- IMOHandrim, Wheelchair
- INAHill Holder, Wheelchair
- IMZHolder, Crutch And Cane, Wheelchair
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- FSALift, Patient, Non-Ac-Powered
- FNMMattress, Air Flotation, Alternating Pressure
- IKYMattress, Flotation Therapy, Non-Powered
- CAFNebulizer (Direct Patient Interface)
- FMQRestraint, Protective
- KIDRestraint, Wheelchair, Non-Protective
- IMSSupport, Head And Trunk, Wheelchair
- JFBTable, Physical Therapy, Multi Function
- LAWTheophylline Control Materials
- INPTips And Pads, Cane, Crutch And Walker
- LFFUnit, Activation, Breath Control
- BYJUnit, Liquid-Oxygen, Portable
- INIVehicle, Motorized 3-Wheeled
- BZDVentilator, Non-Continuous (Respirator)
- ITJWalker, Mechanical
- IORWheelchair, Mechanical
- ITIWheelchair, Powered
Recall records
Showing 25 of 68| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1251-2024 | 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 | Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components | Class II | Open, Classified | |
| Z-2445-2023 | 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 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATOR | Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat can break, and in a worst-case crossbar also breaks and the Rollator can collapse causing injury to user | Class II | Open, Classified | |
| Z-1369-2022 | Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model) | Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required. | Class III | Open, Classified | |
| Z-1130-2022 | Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V | The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to the wheelchair. The disconnection of the battery harness results in loss of power to the wheelchair. | Class II | Open, Classified | |
| Z-0447-2022 | 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 | Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential injury | Class II | Open, Classified | |
| Z-0446-2022 | 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 | Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential injury | Class II | Open, Classified | |
| Z-0445-2022 | 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, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG | Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential injury | Class II | Open, Classified | |
| Z-0514-2021 | Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada), All World: IRC5PO2VAW, IRC5PO2VAWL2, IRC5PO2VAWL3, IRC5PO2VAWL4, IRC5PO2VAWL5 | Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure that can result in self-extinguishing fires or cap explosions. | Class II | Terminated | |
| Z-0549-2019 | 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 bed to a wheelchair. The device includes straps and a sling to support the patient. | Invacare has identified via customer complaints, the potential for the mounting bolt connecting the caster to the base frame of the patient lifts to become loose. Loose hardware can cause wear to the hardware and housings. If left unresolved, the caster may separate from the base of the lift causing the Lift to tilt and a patient fall. Failure does not occur right away but happens over time if the lift is not properly maintained. Patient falls are inherently dangerous and may result in a range of injuries that are dependent on physical condition of the patient and the nature of the fall. When injuries occur, they are typically non-serious injuries such as bruising, lacerations, or abrasions. In rare cases, more serious injuries such as bone fracture, head trauma, or death can occur. For caregivers using the lift, attempts to manually stabilize a lift if it becomes unstable could result in sprains, serious back injuries, or bone fractures. | Class II | Terminated | |
| Z-2218-2017 | Assist Bed Rail - 6632 | A typographical error was noted within the user manual for the 6632 Assist Bed Rail which could result in the Assist Bed Rails being installed incorrectly. | Class II | Terminated | |
| Z-1185-2017 | Junction Box - 1104343 and 1193560 | A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire. | Class II | Terminated | |
| Z-1184-2017 | Foot Section - BAR5490IVC | A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire. | Class II | Terminated | |
| Z-1183-2017 | Bariatric Bed - BARPKG-IVC 1633 | A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire. | Class II | Terminated | |
| Z-1182-2017 | Bariatric Bed - BAR600IVC | The junction box used in the bariatric bed may emit sparks and result in a fire. | Class II | Terminated | |
| Z-2365-2016 | 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 a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow. | The rear gradation scale was screen printed upside down on the flowmeter gauge. | Class II | Terminated | |
| Z-2364-2016 | 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 scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow. | The rear gradation scale was screen printed upside down on the flowmeter gauge. | Class II | Terminated | |
| Z-2402-2016 | 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. | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials. | Class II | Terminated | |
| Z-2401-2016 | 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 adjustable surface contours. | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials. | Class II | Terminated | |
| Z-2400-2016 | 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 adjustable surface contours. | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials. | Class II | Terminated | |
| Z-2399-2016 | 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 adjustable surface contours. | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials. | Class II | Terminated | |
| Z-2358-2015 | Invacare Pronto Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900. | The batteries used in the Invacare Pronto Air Personal Transporter models power wheelchairs have the possibility to overheat during charging which could potentially result in leaking battery acid and/or swelling battery, loss of use, chemical burns and/or property damage. | Class II | Terminated | |
| Z-1139-2015 | 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. | If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. Smoking, sparking, burning or fire may occur if a wire is repetitively pinched at the same place. | Class II | Terminated | |
| Z-1138-2015 | 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. | If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. Smoking, sparking, burning or fire may occur if a wire is repetitively pinched at the same place. | Class II | Terminated | |
| Z-1137-2015 | 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. | If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. Smoking, sparking, burning or fire may occur if a wire is repetitively pinched at the same place. | Class II | Terminated | |
| Z-1036-2015 | G- Series Beds; G29 full length bed rails assembly | Invacare identified that the rail mounting bracket on the G29 full length bed rail was out of specification for entrapment safety. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Invacare GmbH edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain