Data / Medical devices / United States / Invacare Corp. Dba Invacare America
Invacare Corp. Dba Invacare America: FDA-registered device maker in N Ridgeville, OH, United States, 14 510(k) clearances
Invacare Corp. Dba Invacare America is registered with the FDA (registration 1531186) in N Ridgeville, OH, United States. It lists 31 device types. The FDA files 14 510(k) clearances under its listings, the newest dated September 15, 2023. 20 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1531186
- FEI number
- 3002889431
- Address
- 38850 Taylor Parkway, N Ridgeville, OH, United States, 44035
- Owner or operator
- Invacare Corporation dba Invacare America (1525712)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 21, 1977
- Registered through
- 2026
- Brand names listed
- 120A, Dual Motor, Power Controller, 120A, Dual Motor, Power Controller with Lights and 2 Actuator Channels, 2-Channel Actuator Module, 2D Dynamic Footrest Hanger, 4-Channel Actuator Module, 4-Switch Proximity, 4-way expansion block (harness for expandable systems), 9000 Jymni Pediatric Manual Wheelchair and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Adaptor, Hygiene | ILS | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Adult Portable Bed Rails For Medical Purposes | QTC | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Aid, Transfer | IKX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Armrest, Wheelchair | IML | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bariatric Bed | OSI | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bed, Therapeutic, Ac-Powered, Adjustable Home-Use | LLI | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Belt, Wheelchair | IQB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Board, Lap, Wheelchair | IMX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Brake, Extension, Wheelchair | IMW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Chair, With Casters | INM | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Climber, Curb, Wheelchair | IMN | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Components, Wheelchair | KNN | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cover, Mattress (Medical Purposes) | FMW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cushion, Wheelchair | IMP | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Device, Anti-Tip, Wheelchair | IMR | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Footrest, Wheelchair | IMM | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Handrim, Wheelchair | IMO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Hill Holder, Wheelchair | INA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Holder, Crutch And Cane, Wheelchair | IMZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Lift, Patient, Non-Ac-Powered | FSA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mattress, Air Flotation, Alternating Pressure | FNM | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Mattress, Flotation Therapy, Non-Powered | IKY | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Restraint, Protective | FMQ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Restraint, Wheelchair, Non-Protective | KID | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Support, Head And Trunk, Wheelchair | IMS | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tips And Pads, Cane, Crutch And Walker | INP | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Unit, Activation, Breath Control | LFF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 15, 2023 | K232198 | Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF) | IOR | Substantially Equivalent | Zhenjiang Assure Medical Equipment Co., Ltd. | accessdata.fda.gov |
| March 19, 2021 | K202379 | Invacare AVIVA Storm RX Power Chair | ITI | Substantially Equivalent | Invacare Corporation | accessdata.fda.gov |
| January 2, 2020 | K192216 | Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP | ITI | Substantially Equivalent | Invacare Corporation | accessdata.fda.gov |
| December 11, 2018 | K182946 | Invacare TDX SP2-HD with Captain's Seat | ITI | Substantially Equivalent | Invacare Corporation | accessdata.fda.gov |
| November 14, 2018 | K181090 | Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs | IOR | Substantially Equivalent | Invacare Corporation | accessdata.fda.gov |
| July 12, 2017 | 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 | Invacare Corporation | accessdata.fda.gov |
| April 17, 2017 | K162621 | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair | IOR | Substantially Equivalent | Invacare Corporation | accessdata.fda.gov |
| January 9, 2015 | K141783 | TDX SP2 POWER WHEECHAIR | ITI | Substantially Equivalent | Invacare Corporation | accessdata.fda.gov |
| April 18, 2012 | K112816 | ZHENJIANG ASURE MECHANICAL WHEELCHAIR | IOR | Substantially Equivalent | Zhenjiang Assure Medical Equipment Co., Ltd. | accessdata.fda.gov |
| March 16, 2006 | K060582 | INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR | IOR | Substantially Equivalent | Invacare Corporation | accessdata.fda.gov |
| October 5, 2005 | K052468 | YK9000 SERIES MANUAL WHEELCHAIR | IOR | Substantially Equivalent | Intco Metal Products (Zhenjiang) Co., Ltd. | accessdata.fda.gov |
| August 4, 2000 | K002170 | MODEL 9000 PEDIATRIC WHEELCHAIR | IOR | Substantially Equivalent | Invacare Corp. | accessdata.fda.gov |
| March 1, 1994 | K935398 | TRACER SERIES MANUAL WHEELCHAIRS | IOR | Substantially Equivalent | Invacare Corp. | accessdata.fda.gov |
| May 19, 1988 | K881951 | RIDE-LITE 9000 SERIES WHEELCHAIR | IOR | Substantially Equivalent | Invacare Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 22, 2024 | 93875 | Class II | Ongoing | 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 | accessdata.fda.gov |
| December 2, 2016 | 75939 | Class II | Terminated | Bariatric Bed - BAR600IVC | The junction box used in the bariatric bed may emit sparks and result in a fire. | accessdata.fda.gov |
| June 21, 2016 | 74581 | Class II | Terminated | 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 f | The rear gradation scale was screen printed upside down on the flowmeter gauge. | accessdata.fda.gov |
| February 2, 2015 | 71613 | Class II | Terminated | Invacare Pronto Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, -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. | accessdata.fda.gov |
| September 10, 2012 | 64044 | Class II | Terminated | Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position. | The potential exists for the wheel to rotate freely despite engagement of hub brake. | accessdata.fda.gov |
| August 6, 2012 | 62965 | Class II | Terminated | 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 showering and provide comfort | On August 6, 2012, Invacare voluntarily recalled the Invacare I-Fit" Shower Chair (Models 9780, 9781, 9781-1) based on the return, quality and adverse event data received. | accessdata.fda.gov |
| April 16, 2012 | 67134 | Class II | Terminated | 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 living in a home or comm | The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled. | accessdata.fda.gov |
| April 6, 2012 | 61550 | Not yet classified | Terminated | 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. | Adverse event data prompted testing of device, which revealed that the rod supporting the knee pad was not made to specifications. Upon placing a load on the knee pad, the rod may break or bend causing the walker to collapse. As a result, the user may fall. | accessdata.fda.gov |
| February 10, 2012 | 61160 | Not yet classified | Terminated | 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, motor driven device with | Invacare Corporation decided to recall the product because use of this actuator could result in reduced cross sectional current carrying area due to wear/chafing of the wires. | accessdata.fda.gov |
| December 7, 2011 | 60670 | Not yet classified | Terminated | 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. | Invacare Corporation decided to recall the products because the scooter backrest fails unexpectedly due to seat flexing, and this has the potential to result in a consumer falling causing death or serious injury. | accessdata.fda.gov |
| January 11, 2011 | 57629 | Not yet classified | Terminated | HomeFill Oxygen Compressor IOH200 Homefill, The serial numbers are as follows: 10JF034081, 10JF034082, 10JF034083, 10JF034084, 10JF034085, 10JF034086, 10JF034087, 10JF034088, 10JF034089, 10JF034090, 10JF034091, 10JF03409 | Invacare Corporation decided to recall the products because risk analysis reveals that inadequate clearance between a motor ground clip and the motor windings may result in an increased risk for shock to service personnel. It also may result in contact with the motor winding, resulting in a shorted winding; this condition has the potential to result in motor | accessdata.fda.gov |
| June 15, 2009 | 52445 | Not yet classified | Terminated | Kuschall K Junior Manual wheelchair | The handle has been breaking at a calculated weight of 65 kg which may have serious consequences (broken bones) depending on the circumstances of the break (e.g., user on ramps, hills, etc.). | accessdata.fda.gov |
| March 19, 2007 | 37929 | Not yet classified | Terminated | Invacare Storm TDX Power Wheelchair, Models: #TDX3-PS, TDX3-SE-PS, TDX4-PS. | Software error may permit the chair to recline too far. | accessdata.fda.gov |
| July 18, 2006 | 35910 | Not yet classified | Terminated | Kuschall''s K3/K4 Series of Manual Wheelchair, Model Airlite. | If the user has chosen to install optional anti-tippers on the chair, the anti-tipper as designed may not be able to bear the stress of repeated or quick loads placed on it, causing the bolt to bend or break. | accessdata.fda.gov |
| June 27, 2006 | 35772 | Not yet classified | Terminated | Solara 2G manual wheelchair. | The wheelchairs with the Travel Ready Option (TRRO) may contain incorrectly finished oval tie down brackets. The inner edge of the bracket may cause the tie-down straps (used to tie down the chairs during transport) to fray or be cut. | accessdata.fda.gov |
| June 14, 2006 | 35681 | Not yet classified | Terminated | Pronto M51 Wheelchair, component- seat | Some of the wheelchairs were distributed with seats that did not have a seat positioning strap. | accessdata.fda.gov |
| October 11, 2005 | 33772 | Not yet classified | Terminated | 3G Storm Series Power Wheelchair with Power Tilt Option. | When the powered seating system is tilted completely in the rearward position, a potential pinch point is created between the seat and the seat frame. | accessdata.fda.gov |
| May 2, 2005 | 32009 | Not yet classified | Terminated | Pronto Series Power Wheelchair, model M50. | If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. This failure may cause the user or a caregiver to fall if they are leaning on the arm, and result in injury. | accessdata.fda.gov |
| July 23, 2004 | 29665 | Not yet classified | Terminated | ICCG AC-Powered Adjustable Medical Bed | Component Defect. Metal Oxide Varister (MOV) component of the junction box may short circuit with the potential for device failure. | accessdata.fda.gov |
| June 9, 2003 | 26479 | Not yet classified | Terminated | Invacare IVC Home Care Bed (Foot Section with new head actuator from Linak. | Pull tube on bed may bend or separate causing inoperability of bed or head section to fall. | accessdata.fda.gov |
Compare with other makers
- All makers of Board, Lap, Wheelchair
- All makers of Mattress, Flotation Therapy, Non-Powered
- All makers of Wheelchair, Mechanical
- All makers of Lift, Patient, Non-Ac-Powered
- All makers of Walker, Mechanical
- All makers of Restraint, Protective
Updated March 4, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.