{
  "companyId": "50015",
  "slug": "invacare-corporation-50015",
  "name": "Invacare Corporation",
  "clearances": {
    "total": 131,
    "last12Months": 0,
    "first": "1980-07-21",
    "latest": "2021-04-12"
  },
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  "productCodeCount": 20,
  "recalls": {
    "total": 68,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-1251-2024",
        "productCode": "LLI",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-01-22",
        "reason": "Invacare Homecare & G-Series Bed Components\nidentified with a potential weld defect leads to premature weld failures to occur on these components"
      },
      {
        "resNumber": "Z-2445-2023",
        "productCode": "ITJ",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2023-06-15",
        "reason": "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"
      },
      {
        "resNumber": "Z-1369-2022",
        "productCode": "CAW",
        "status": "Open, Classified",
        "recallClass": "Class III",
        "initiated": "2022-06-10",
        "reason": "Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the \"Rx Only\" statement as required."
      },
      {
        "resNumber": "Z-1130-2022",
        "productCode": "ITI",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2022-03-30",
        "reason": "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."
      },
      {
        "resNumber": "Z-0445-2022",
        "productCode": "ITI",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2021-11-12",
        "reason": "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"
      }
    ]
  },
  "registration": {
    "sites": 2,
    "countries": [
      "US"
    ]
  },
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    {
      "code": "ITI",
      "deviceName": "Wheelchair, Powered",
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      "latest": "2021-03-19",
      "medianReviewDays": 82
    },
    {
      "code": "IOR",
      "deviceName": "Wheelchair, Mechanical",
      "clearances": 32,
      "latest": "2018-11-14",
      "medianReviewDays": 20
    },
    {
      "code": "CAW",
      "deviceName": "Generator, Oxygen, Portable",
      "clearances": 20,
      "latest": "2021-04-12",
      "medianReviewDays": 110
    },
    {
      "code": "BXB",
      "deviceName": "Exerciser, Powered",
      "clearances": 8,
      "latest": "1989-03-15",
      "medianReviewDays": 74
    },
    {
      "code": "BZD",
      "deviceName": "Ventilator, Non-Continuous (Respirator)",
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      "latest": "2007-04-30",
      "medianReviewDays": 187
    },
    {
      "code": "INI",
      "deviceName": "Vehicle, Motorized 3-Wheeled",
      "clearances": 5,
      "latest": "2003-03-20",
      "medianReviewDays": 12
    },
    {
      "code": "CAF",
      "deviceName": "Nebulizer (Direct Patient Interface)",
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      "latest": "2005-01-06",
      "medianReviewDays": 87
    },
    {
      "code": "INO",
      "deviceName": "Chair, Positioning, Electric",
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      "latest": "2006-09-21",
      "medianReviewDays": 35
    },
    {
      "code": "BTT",
      "deviceName": "Humidifier, Respiratory Gas, (Direct Patient Interface)",
      "clearances": 2,
      "latest": "2004-03-25",
      "medianReviewDays": 148
    },
    {
      "code": "FNL",
      "deviceName": "Bed, Ac-Powered Adjustable Hospital",
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      "latest": "1998-01-06",
      "medianReviewDays": 50
    },
    {
      "code": "NFB",
      "deviceName": "Conserver, Oxygen",
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      "latest": "2000-10-24",
      "medianReviewDays": 90
    },
    {
      "code": "BYJ",
      "deviceName": "Unit, Liquid-Oxygen, Portable",
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      "latest": "1993-08-31",
      "medianReviewDays": 256
    },
    {
      "code": "CCL",
      "deviceName": "Analyzer, Gas, Oxygen, Gaseous-Phase",
      "clearances": 1,
      "latest": "1999-07-09",
      "medianReviewDays": 220
    },
    {
      "code": "DPS",
      "deviceName": "Electrocardiograph",
      "clearances": 1,
      "latest": "1987-12-15",
      "medianReviewDays": 169
    },
    {
      "code": "FNM",
      "deviceName": "Mattress, Air Flotation, Alternating Pressure",
      "clearances": 1,
      "latest": "1996-03-18",
      "medianReviewDays": 49
    },
    {
      "code": "FSA",
      "deviceName": "Lift, Patient, Non-Ac-Powered",
      "clearances": 1,
      "latest": "1984-04-17",
      "medianReviewDays": 40
    },
    {
      "code": "IKZ",
      "deviceName": "Bed, Patient Rotation, Powered",
      "clearances": 1,
      "latest": "1995-05-16",
      "medianReviewDays": 91
    },
    {
      "code": "JFB",
      "deviceName": "Table, Physical Therapy, Multi Function",
      "clearances": 1,
      "latest": "1984-11-23",
      "medianReviewDays": 73
    },
    {
      "code": "KNN",
      "deviceName": "Components, Wheelchair",
      "clearances": 1,
      "latest": "1992-01-09",
      "medianReviewDays": 23
    },
    {
      "code": "LAW",
      "deviceName": "Theophylline Control Materials",
      "clearances": 1,
      "latest": "1992-01-24",
      "medianReviewDays": 123
    }
  ],
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  "productCodesTotal": "20",
  "recentClearances": [
    {
      "kNumber": "K203210",
      "deviceName": "Invacare Platinum 5NXG Oxygen Concentrator",
      "productCode": "CAW",
      "decisionDate": "2021-04-12",
      "reviewDays": 164
    },
    {
      "kNumber": "K202379",
      "deviceName": "Invacare AVIVA Storm RX Power Chair",
      "productCode": "ITI",
      "decisionDate": "2021-03-19",
      "reviewDays": 211
    },
    {
      "kNumber": "K200890",
      "deviceName": "Invacare Perfecto2V Oxygen Concentrator",
      "productCode": "CAW",
      "decisionDate": "2020-08-06",
      "reviewDays": 125
    },
    {
      "kNumber": "K192216",
      "deviceName": "Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP",
      "productCode": "ITI",
      "decisionDate": "2020-01-02",
      "reviewDays": 140
    },
    {
      "kNumber": "K191159",
      "deviceName": "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",
      "productCode": "CAW",
      "decisionDate": "2019-08-29",
      "reviewDays": 120
    },
    {
      "kNumber": "K182946",
      "deviceName": "Invacare TDX SP2-HD with Captain's Seat",
      "productCode": "ITI",
      "decisionDate": "2018-12-11",
      "reviewDays": 49
    },
    {
      "kNumber": "K181090",
      "deviceName": "Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs",
      "productCode": "IOR",
      "decisionDate": "2018-11-14",
      "reviewDays": 203
    },
    {
      "kNumber": "K170507",
      "deviceName": "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",
      "productCode": "ITI",
      "decisionDate": "2017-07-12",
      "reviewDays": 141
    },
    {
      "kNumber": "K162621",
      "deviceName": "Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair",
      "productCode": "IOR",
      "decisionDate": "2017-04-17",
      "reviewDays": 209
    },
    {
      "kNumber": "K162696",
      "deviceName": "Kuschall Advance Manual Wheelchair",
      "productCode": "IOR",
      "decisionDate": "2016-12-28",
      "reviewDays": 92
    }
  ],
  "nameVariants": {
    "total": "7",
    "shown": [
      {
        "name": "INVACARE CORP. DBA INVACARE AMERICA",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Invacare Corp",
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        "method": "normalised"
      },
      {
        "name": "Invacare Corp.",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Invacare Corporation",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Invacare Corporation",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Invacare Corporation",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Invacare GmbH",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Invacare%20Corporation%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Invacare%20Corporation%22"
  },
  "provenance": [
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      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
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    },
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      "loadedAt": "2026-08-10T19:40:12Z",
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    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
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    },
    {
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      "loadedAt": "2026-08-10T19:40:11Z",
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    },
    {
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      "loadedAt": "2026-08-10T07:06:24Z",
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  ],
  "retrievedAt": "2026-08-11T14:48:53.035Z"
}
