{
  "code": "IOR",
  "deviceName": "Wheelchair, Mechanical",
  "deviceClass": "I",
  "regulationNumber": "890.3850",
  "panel": "Physical Medicine",
  "definition": "A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and/or require an assistive device for mobility.",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 462,
    "last12Months": 16
  },
  "adverseEvents": {
    "total": 414,
    "last12Months": 42
  },
  "reviewDays": {
    "median": 46,
    "sampleSize": 462
  },
  "recalls": {
    "total": 40,
    "recent": [
      {
        "resNumber": "Z-0264-2022",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "TiSport, Llc",
        "firmAsPublished": "TiSport, Llc",
        "reason": "Some affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor vehicle may not be configured in the right orientation to perform as intended if involved in a motor vehicle accident. Some affected wheelchairs can no longer be used as a passenger seat until transit tie downs are replaced with redesigned transit tie downs, verified, and released to the market.",
        "initiated": "2021-09-24"
      },
      {
        "resNumber": "Z-2294-2019",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "TiSport, Llc",
        "firmAsPublished": "TiSport, Llc",
        "reason": "The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards.",
        "initiated": "2018-09-11"
      },
      {
        "resNumber": "Z-2290-2016",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Sunrise Medical (US) LLC",
        "firmAsPublished": "Sunrise Medical (US) LLC",
        "reason": "There is an observed failure of the backrest bracket which can fatigue over the life time of the product. When this occurs there is the possibility of the bracket fracturing\ncausing the backrest to detach from the chair frame.",
        "initiated": "2016-07-01"
      },
      {
        "resNumber": "Z-1025-2016",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Karman Healthcare Inc",
        "firmAsPublished": "Karman Healthcare Inc",
        "reason": "Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork brackets.",
        "initiated": "2016-01-27"
      },
      {
        "resNumber": "Z-2466-2015",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Sunrise Medical (US) LLC",
        "firmAsPublished": "Sunrise Medical (US) LLC",
        "reason": "Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant.",
        "initiated": "2015-07-27"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K252370",
      "deviceName": "GEN 4 JOY Wheelchair",
      "applicant": "Free Wheelchair Mission",
      "company": "Free Wheelchair Mission",
      "decisionDate": "2026-07-24",
      "dateReceived": "2025-07-30"
    },
    {
      "kNumber": "K261076",
      "deviceName": "Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)",
      "applicant": "GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.",
      "company": "GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.",
      "decisionDate": "2026-06-22",
      "dateReceived": "2026-04-01"
    },
    {
      "kNumber": "K261075",
      "deviceName": "Manual Wheelchair (MS01);Manual Wheelchair (MA01)",
      "applicant": "GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.",
      "company": "GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.",
      "decisionDate": "2026-06-22",
      "dateReceived": "2026-04-01"
    },
    {
      "kNumber": "K260849",
      "deviceName": "ICON 35; ICON 45; ICON 60; ICON 30FAF",
      "applicant": "Rehasense USA, Inc.",
      "company": "Rehasense USA, Inc.",
      "decisionDate": "2026-06-11",
      "dateReceived": "2026-03-16"
    },
    {
      "kNumber": "K260642",
      "deviceName": "Manual Wheelchair (LW01108)",
      "applicant": "Anhui Longway Medical Technology Co., Ltd.",
      "company": "Anhui Longway Medical Technology Co., Ltd.",
      "decisionDate": "2026-06-02",
      "dateReceived": "2026-02-27"
    },
    {
      "kNumber": "K260295",
      "deviceName": "Helio Kids; Apex P",
      "applicant": "Motion Composites",
      "company": "Motion Composites",
      "decisionDate": "2026-05-28",
      "dateReceived": "2026-01-29"
    },
    {
      "kNumber": "K254141",
      "deviceName": "Manual Wheelchair (DY01903(2))",
      "applicant": "Guangdong Dayang Medical Technology Co., Ltd.",
      "company": "Guangdong Dayang Medical Technology Co., Ltd.",
      "decisionDate": "2026-05-21",
      "dateReceived": "2025-12-22"
    },
    {
      "kNumber": "K260121",
      "deviceName": "Manual Wheelchair (7101L, 7102LHD)",
      "applicant": "Foshan Nanhai Hongchen Medical Equipment Co., Ltd.",
      "company": "Foshan Nanhai Hongchen Medical Equipment Co., Ltd.",
      "decisionDate": "2026-04-28",
      "dateReceived": "2026-01-15"
    },
    {
      "kNumber": "K260319",
      "deviceName": "K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR))",
      "applicant": "Zhenjiang Assure Medical Equipment Co., Ltd.",
      "company": "Zhenjiang Assure Medical Equipment Co., Ltd.",
      "decisionDate": "2026-03-31",
      "dateReceived": "2026-01-30"
    },
    {
      "kNumber": "K253632",
      "deviceName": "Manual Wheelchair (W50)",
      "applicant": "Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.",
      "company": "JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD",
      "decisionDate": "2026-01-29",
      "dateReceived": "2025-11-19"
    }
  ],
  "topApplicants": [
    {
      "name": "Invacare Corp.",
      "count": 24
    },
    {
      "name": "Colours 'N Motion",
      "count": 12
    },
    {
      "name": "Freedom Designs, Inc.",
      "count": 10
    },
    {
      "name": "Everest & Jennings, Inc.",
      "count": 9
    },
    {
      "name": "Invacare Corporation",
      "count": 8
    }
  ],
  "topCompanies": [
    {
      "name": "Invacare Corporation",
      "count": 32,
      "spellings": 2
    },
    {
      "name": "Colours 'N Motion",
      "count": 12,
      "spellings": 1
    },
    {
      "name": "Freedom Designs, Inc.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Everest & Jennings, Inc.",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Sunrise Medical, Inc.",
      "count": 9,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.",
      "since": "2026-06-22",
      "kNumber": "K261075"
    },
    {
      "name": "Rehasense USA, Inc.",
      "since": "2026-06-11",
      "kNumber": "K260849"
    },
    {
      "name": "Anhui Longway Medical Technology Co., Ltd.",
      "since": "2026-06-02",
      "kNumber": "K260642"
    },
    {
      "name": "Guangdong Dayang Medical Technology Co., Ltd.",
      "since": "2026-05-21",
      "kNumber": "K254141"
    },
    {
      "name": "Foshan Nanhai Hongchen Medical Equipment Co., Ltd.",
      "since": "2026-04-28",
      "kNumber": "K260121"
    },
    {
      "name": "Empower Ride, LLC",
      "since": "2026-01-12",
      "kNumber": "K251886"
    },
    {
      "name": "SUZHOU MASTER MACHINERY MANUFACTURING CO.,LTD.",
      "since": "2025-11-21",
      "kNumber": "K252687"
    },
    {
      "name": "Karma Mobility Co, Ltd.",
      "since": "2025-11-04",
      "kNumber": "K250576"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 28,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 61,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 17,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 13,
        "expectedLow": 2.3474749330736677,
        "expectedHigh": 24.041739536209523,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 12,
        "expectedLow": 3.6737759650753348,
        "expectedHigh": 19.328267605612485,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 15,
        "expectedLow": 5.094411318535243,
        "expectedHigh": 21.202456126990572,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 17,
        "expectedLow": 5.700843834888155,
        "expectedHigh": 22.60060673236358,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 19,
        "expectedLow": 5.728849657052086,
        "expectedHigh": 22.29110872460438,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 2,
        "expectedLow": 6.956646017221742,
        "expectedHigh": 25.08067605821002,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 23,
        "expectedLow": 3.138195883351932,
        "expectedHigh": 34.28024792489616,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 7,
        "expectedLow": 3.646337104363562,
        "expectedHigh": 26.81109475127962,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 1,
        "expectedLow": 0.27767457509856336,
        "expectedHigh": 26.227690294356545,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 24.702322233391588,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 22.118088337568025,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 8,
        "expectedLow": 0,
        "expectedHigh": 23.514409867710135,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 27.18641745487211,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 22.023173131227402,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 24.15390809243942,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "IOR (Wheelchair, Mechanical) has three findings, most consequential first. 8 first-time filers in the last 12 months, including GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. and Rehasense USA, Inc (K261075, K260849, K260642, K254141, K260121). Clearances are running 98% slower — a median 91 days over the last 12 months against 46 days all-time (elapsed calendar days, not FDA review days) (IOR:review_time:12m). The code is crowded, scoring 100 of 100 — 259 companies hold a clearance here and 16 arrived in the last 12 months (IOR:crowding).",
    "severity": 48,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "8 first-time filers in the last 12 months, including GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. and Rehasense USA, Inc.",
        "recordIds": [
          "K261075",
          "K260849",
          "K260642",
          "K254141",
          "K260121"
        ],
        "severity": 48
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 98% slower — a median 91 days over the last 12 months against 46 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "IOR:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 100 of 100 — 259 companies hold a clearance here and 16 arrived in the last 12 months",
        "recordIds": [
          "IOR:crowding"
        ],
        "severity": 20
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AIOR"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AIOR"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AIOR"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AIOR"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AIOR"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AIOR"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AIOR"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.712Z"
}