{
  "code": "ITI",
  "deviceName": "Wheelchair, Powered",
  "deviceClass": "II",
  "regulationNumber": "890.3860",
  "panel": "Physical Medicine",
  "definition": "A powered wheelchair is a battery-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 require an assistive device for mobility.  NOTE: This type of device is not intended to climb stairs (see product code: IMK).",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 585,
    "last12Months": 34
  },
  "adverseEvents": {
    "total": 1340,
    "last12Months": 754
  },
  "reviewDays": {
    "median": 86,
    "sampleSize": 585
  },
  "recalls": {
    "total": 71,
    "recent": [
      {
        "resNumber": "Z-2841-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Pride Mobility Products Corp.",
        "firmAsPublished": "Pride Mobility Products Corp.",
        "reason": "If the \"Remind Me Later\" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.",
        "initiated": "2026-06-25"
      },
      {
        "resNumber": "Z-2842-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Pride Mobility Products Corp.",
        "firmAsPublished": "Pride Mobility Products Corp.",
        "reason": "If the \"Remind Me Later\" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.",
        "initiated": "2026-06-25"
      },
      {
        "resNumber": "Z-2843-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Pride Mobility Products Corp.",
        "firmAsPublished": "Pride Mobility Products Corp.",
        "reason": "If the \"Remind Me Later\" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.",
        "initiated": "2026-06-25"
      },
      {
        "resNumber": "Z-2844-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Pride Mobility Products Corp.",
        "firmAsPublished": "Pride Mobility Products Corp.",
        "reason": "If the \"Remind Me Later\" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.",
        "initiated": "2026-06-25"
      },
      {
        "resNumber": "Z-2845-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Pride Mobility Products Corp.",
        "firmAsPublished": "Pride Mobility Products Corp.",
        "reason": "If the \"Remind Me Later\" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.",
        "initiated": "2026-06-25"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261149",
      "deviceName": "Electric Wheelchair (DY611A-2, DY612A-1)",
      "applicant": "Zhejiang Lumbre Electric Appliance Co., Ltd.",
      "company": "Zhejiang Lumbre Electric Appliance Co., Ltd.",
      "decisionDate": "2026-07-10",
      "dateReceived": "2026-04-08"
    },
    {
      "kNumber": "K261396",
      "deviceName": "Electric Wheelchair",
      "applicant": "Ningbo Resshidi Medical Devices Co., Ltd.",
      "company": "Ningbo Resshidi Medical Devices Co., Ltd.",
      "decisionDate": "2026-07-08",
      "dateReceived": "2026-04-29"
    },
    {
      "kNumber": "K261164",
      "deviceName": "Electric wheelchair (XW-LY007 )",
      "applicant": "Yongkang Ruihe Metal Product Co., Ltd.",
      "company": "Yongkang Ruihe Metal Product Co., Ltd.",
      "decisionDate": "2026-07-07",
      "dateReceived": "2026-04-09"
    },
    {
      "kNumber": "K260937",
      "deviceName": "Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)",
      "applicant": "Shanghai Waylong Intelligent Technology Co.,Ltd",
      "company": "Shanghai Waylong Intelligent Technology Co.,Ltd",
      "decisionDate": "2026-06-24",
      "dateReceived": "2026-03-20"
    },
    {
      "kNumber": "K253812",
      "deviceName": "Power Wheelchair (W5915B, W5915C, W5915D)",
      "applicant": "Zhejiang Innuovo Rehabilitation Devices Co.,Ltd",
      "company": "ZHEJIANG INNUOVO REHABILITATION DEVICES CO., LTD.",
      "decisionDate": "2026-06-18",
      "dateReceived": "2025-11-28"
    },
    {
      "kNumber": "K260335",
      "deviceName": "Electric Wheelchair (S500-6)",
      "applicant": "Zhongshan Sulenz Intelligent Technology Co., Ltd.",
      "company": "Zhongshan Sulenz Intelligent Technology Co., Ltd.",
      "decisionDate": "2026-06-15",
      "dateReceived": "2026-02-02"
    },
    {
      "kNumber": "K261175",
      "deviceName": "WHILL (WHILL Model C2)",
      "applicant": "Whill, Inc.",
      "company": "WHILL, INC.",
      "decisionDate": "2026-06-12",
      "dateReceived": "2026-04-10"
    },
    {
      "kNumber": "K260056",
      "deviceName": "Power Wheelchair (N5515A, N5516, N5517A, N5519)",
      "applicant": "Zhejiang Innuovo Rehabilitation Devices Co.,Ltd",
      "company": "ZHEJIANG INNUOVO REHABILITATION DEVICES CO., LTD.",
      "decisionDate": "2026-06-05",
      "dateReceived": "2026-01-08"
    },
    {
      "kNumber": "K260373",
      "deviceName": "Electric Wheelchair (DF506)",
      "applicant": "Jiangsu Yveelt Medical Equipment Co., Ltd.",
      "company": "Jiangsu Yveelt Medical Equipment Co., Ltd.",
      "decisionDate": "2026-06-03",
      "dateReceived": "2026-02-05"
    },
    {
      "kNumber": "K253241",
      "deviceName": "Electric Wheelchair (Y207BL)",
      "applicant": "Jiangsu Intco Medical Products Co., Ltd.",
      "company": "Jiangsu Intco Medical Products Co., Ltd.",
      "decisionDate": "2026-05-13",
      "dateReceived": "2025-09-29"
    }
  ],
  "topApplicants": [
    {
      "name": "Invacare Corp.",
      "count": 32
    },
    {
      "name": "Fortress Scientific , Ltd.",
      "count": 19
    },
    {
      "name": "Everest & Jennings, Inc.",
      "count": 17
    },
    {
      "name": "Hoveround Corp.",
      "count": 15
    },
    {
      "name": "Permobil AB",
      "count": 11
    }
  ],
  "topCompanies": [
    {
      "name": "Invacare Corporation",
      "count": 38,
      "spellings": 2
    },
    {
      "name": "Fortress Scientific , Ltd.",
      "count": 19,
      "spellings": 1
    },
    {
      "name": "Everest & Jennings, Inc.",
      "count": 17,
      "spellings": 1
    },
    {
      "name": "Hoveround Corp.",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "Permobil, Ab",
      "count": 11,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Zhejiang Lumbre Electric Appliance Co., Ltd.",
      "since": "2026-07-10",
      "kNumber": "K261149"
    },
    {
      "name": "Ningbo Resshidi Medical Devices Co., Ltd.",
      "since": "2026-07-08",
      "kNumber": "K261396"
    },
    {
      "name": "Yongkang Ruihe Metal Product Co., Ltd.",
      "since": "2026-07-07",
      "kNumber": "K261164"
    },
    {
      "name": "Shanghai Waylong Intelligent Technology Co.,Ltd",
      "since": "2026-06-24",
      "kNumber": "K260937"
    },
    {
      "name": "Zhongshan Sulenz Intelligent Technology Co., Ltd.",
      "since": "2026-06-15",
      "kNumber": "K260335"
    },
    {
      "name": "Jiangsu Yveelt Medical Equipment Co., Ltd.",
      "since": "2026-06-03",
      "kNumber": "K260373"
    },
    {
      "name": "Beijing OrionStar Technology Co., Ltd.",
      "since": "2026-04-07",
      "kNumber": "K253952"
    },
    {
      "name": "Zhongshan A&J Medical Equipment Co., Ltd.",
      "since": "2026-04-03",
      "kNumber": "K253340"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 22,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 34,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 45,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 24,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 21,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 39,
        "expectedLow": 6.05227744338418,
        "expectedHigh": 17.62413619891927,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 36,
        "expectedLow": 2.591017623862895,
        "expectedHigh": 32.137242707537865,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 39,
        "expectedLow": 2.8964230639523914,
        "expectedHigh": 48.402124751929804,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 28,
        "expectedLow": 3.7295771982667376,
        "expectedHigh": 57.51324999653468,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 25,
        "expectedLow": 3.278622588016384,
        "expectedHigh": 52.76701311812518,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 43,
        "expectedLow": 3.0076628419809017,
        "expectedHigh": 53.24869949070704,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 31,
        "expectedLow": 8.37376811639566,
        "expectedHigh": 94.06789762808714,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 38,
        "expectedLow": 3.1216030999540147,
        "expectedHigh": 65.13427798806016,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 20,
        "expectedLow": 6.106936411626942,
        "expectedHigh": 68.18022552874542,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 14,
        "expectedLow": 2.29686570879406,
        "expectedHigh": 61.52124255984224,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 151,
        "expectedLow": 0,
        "expectedHigh": 51.74656352158783,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 168,
        "expectedLow": 0,
        "expectedHigh": 150.41410796019974,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 331,
        "expectedLow": 0,
        "expectedHigh": 235.55927394001588,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 24,
        "expectedLow": 0,
        "expectedHigh": 315.8304163148408,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 18,
        "expectedLow": 0,
        "expectedHigh": 306.5833528749685,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "ITI (Wheelchair, Powered) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Z-2841-2026, Z-2842-2026, Z-2843-2026, Z-2844-2026, Z-2845-2026). 21 first-time filers in the last 12 months, including Zhejiang Lumbre Electric Appliance Co., Ltd. and Ningbo Resshidi Medical Devices Co., Ltd (K261149, K261396, K261164, K260937, K260335). Clearances are running 22% slower — a median 105 days over the last 12 months against 86 days all-time (elapsed calendar days, not FDA review days) (ITI:review_time:12m). The code is crowded, scoring 100 of 100 — 255 companies hold a clearance here and 34 arrived in the last 12 months (ITI:crowding).",
    "severity": 70,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated",
        "recordIds": [
          "Z-2841-2026",
          "Z-2842-2026",
          "Z-2843-2026",
          "Z-2844-2026",
          "Z-2845-2026"
        ],
        "severity": 70
      },
      {
        "kind": "new_entrant",
        "detail": "21 first-time filers in the last 12 months, including Zhejiang Lumbre Electric Appliance Co., Ltd. and Ningbo Resshidi Medical Devices Co., Ltd.",
        "recordIds": [
          "K261149",
          "K261396",
          "K261164",
          "K260937",
          "K260335"
        ],
        "severity": 50
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 22% slower — a median 105 days over the last 12 months against 86 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "ITI:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 100 of 100 — 255 companies hold a clearance here and 34 arrived in the last 12 months",
        "recordIds": [
          "ITI: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%3AITI"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AITI"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AITI"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AITI"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AITI"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AITI"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AITI"
    }
  ],
  "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": "2026-08-11T13:51:45.713Z"
}