{
  "code": "INI",
  "deviceName": "Vehicle, Motorized 3-Wheeled",
  "deviceClass": "II",
  "regulationNumber": "890.3800",
  "panel": "Physical Medicine",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 349,
    "last12Months": 20
  },
  "adverseEvents": {
    "total": 87,
    "last12Months": 17
  },
  "reviewDays": {
    "median": 76,
    "sampleSize": 349
  },
  "recalls": {
    "total": 22,
    "recent": [
      {
        "resNumber": "Z-1505-2021",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Merits Holdings Co. dba Merits Health Products, Inc.",
        "firmAsPublished": "Merits Holdings Co. dba Merits Health Products, Inc.",
        "reason": "Seat baseplate pin has broken in the field.",
        "initiated": "2021-04-01"
      },
      {
        "resNumber": "Z-1235-2014",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Golden Technologies, Inc.",
        "firmAsPublished": "Golden Technologies, Inc.",
        "reason": "Buzzaround XL scooters' front to rear lockup can become unintentionally disengaged due to possible improper fit of the front alignment cup to the rear alignment screw.",
        "initiated": "2014-01-21"
      },
      {
        "resNumber": "Z-0115-2014",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "S.A.E. AFIKIM",
        "firmAsPublished": "S.A.E. AFIKIM",
        "reason": "Breeze C Scooter, motorized 3-wheeled electric scooter for elderly people, is recalled because it may become unresponsive during operation due to an electrical contact which may fault due to extensive wear, which potentially could result in the driver not being able to stop the scooter during operation except by turning off the ignition key.",
        "initiated": "2013-09-27"
      },
      {
        "resNumber": "Z-0774-2012",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Invacare Corporation",
        "firmAsPublished": "Invacare Corporation",
        "reason": "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.",
        "initiated": "2011-12-07"
      },
      {
        "resNumber": "Z-3211-2011",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Pride Mobility Products Corp.",
        "firmAsPublished": "Pride Mobility Products Corp",
        "reason": "Contract manufacturer error.  Component part(s) (fuses) specifications were not adhered to as outlined in Pride's Engineering drawings.",
        "initiated": "2011-06-22"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261232",
      "deviceName": "IERO Mobility Scooter (IERO-01)",
      "applicant": "Jochu Technology Co., Ltd.",
      "company": "Jochu Technology Co., Ltd.",
      "decisionDate": "2026-07-14",
      "dateReceived": "2026-04-15"
    },
    {
      "kNumber": "K261163",
      "deviceName": "Mobility Scooter (R200)",
      "applicant": "Yongkang Ruihe Metal Product Co., Ltd.",
      "company": "Yongkang Ruihe Metal Product Co., Ltd.",
      "decisionDate": "2026-07-07",
      "dateReceived": "2026-04-09"
    },
    {
      "kNumber": "K253257",
      "deviceName": "Virgo Mobility Scooter (Virgo-D,Virgo-F)",
      "applicant": "Jiangsu Intco Medical Products Co., Ltd.",
      "company": "Jiangsu Intco Medical Products Co., Ltd.",
      "decisionDate": "2026-06-08",
      "dateReceived": "2025-09-29"
    },
    {
      "kNumber": "K253600",
      "deviceName": "Scooter (YD-03)",
      "applicant": "Yurob Rehabilitation Medical Co., Ltd.",
      "company": "Yurob Rehabilitation Medical Co., Ltd.",
      "decisionDate": "2026-06-03",
      "dateReceived": "2025-11-18"
    },
    {
      "kNumber": "K260717",
      "deviceName": "Mobility Scooter (Air Carbon)",
      "applicant": "Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.",
      "company": "Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.",
      "decisionDate": "2026-05-20",
      "dateReceived": "2026-03-05"
    },
    {
      "kNumber": "K260237",
      "deviceName": "Mobility Scooter (X-12, X-14, X-17)",
      "applicant": "Wuyi Aichi Industry and Trade Co., Ltd.",
      "company": "Wuyi Aichi Industry and Trade Co., Ltd.",
      "decisionDate": "2026-04-22",
      "dateReceived": "2026-01-26"
    },
    {
      "kNumber": "K252813",
      "deviceName": "Electrical Scooter (SM4226)",
      "applicant": "Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.",
      "company": "Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.",
      "decisionDate": "2026-03-17",
      "dateReceived": "2025-09-04"
    },
    {
      "kNumber": "K253936",
      "deviceName": "Power Mobility Scooter (MJMA01, MJMA02)",
      "applicant": "Nanjing Mijo Technology Co., Ltd.",
      "company": "Nanjing Mijo Technology Co., Ltd.",
      "decisionDate": "2026-03-12",
      "dateReceived": "2025-12-09"
    },
    {
      "kNumber": "K253631",
      "deviceName": "Mobility Scooter (CL-Q3, CL-Q4)",
      "applicant": "Zhejiang Wei Ling New Energy Technology Co., Ltd.",
      "company": "Zhejiang Wei Ling New Energy Technology Co., Ltd.",
      "decisionDate": "2026-02-23",
      "dateReceived": "2025-11-19"
    },
    {
      "kNumber": "K253643",
      "deviceName": "Mobility Scooter (S3)",
      "applicant": "Shenzhen Zhimahuaerkai Technology Co., Ltd.",
      "company": "Shenzhen Zhimahuaerkai Technology Co., Ltd.",
      "decisionDate": "2026-02-18",
      "dateReceived": "2025-11-19"
    }
  ],
  "topApplicants": [
    {
      "name": "Wu'S Tech Co., Ltd.",
      "count": 16
    },
    {
      "name": "Heartway Medical Products Co., Ltd.",
      "count": 15
    },
    {
      "name": "Pride Health Care, Inc.",
      "count": 14
    },
    {
      "name": "C.T.M. Homecare Product, Inc.",
      "count": 11
    },
    {
      "name": "Pride Mobility Products Corp.",
      "count": 10
    }
  ],
  "topCompanies": [
    {
      "name": "Wu'S Tech Co., Ltd.",
      "count": 17,
      "spellings": 2
    },
    {
      "name": "Heartway Medical Products Co., Ltd.",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "Pride Health Care, Inc.",
      "count": 14,
      "spellings": 1
    },
    {
      "name": "C.T.M. Homecare Product, Inc.",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Pride Mobility Products Corp.",
      "count": 10,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Jochu Technology Co., Ltd.",
      "since": "2026-07-14",
      "kNumber": "K261232"
    },
    {
      "name": "Yongkang Ruihe Metal Product Co., Ltd.",
      "since": "2026-07-07",
      "kNumber": "K261163"
    },
    {
      "name": "Jiangsu Intco Medical Products Co., Ltd.",
      "since": "2026-06-08",
      "kNumber": "K253257"
    },
    {
      "name": "Yurob Rehabilitation Medical Co., Ltd.",
      "since": "2026-06-03",
      "kNumber": "K253600"
    },
    {
      "name": "Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.",
      "since": "2026-03-17",
      "kNumber": "K252813"
    },
    {
      "name": "Nanjing Mijo Technology Co., Ltd.",
      "since": "2026-03-12",
      "kNumber": "K253936"
    },
    {
      "name": "Zhejiang Wei Ling New Energy Technology Co., Ltd.",
      "since": "2026-02-23",
      "kNumber": "K253631"
    },
    {
      "name": "Shenzhen Zhimahuaerkai Technology Co., Ltd.",
      "since": "2026-02-18",
      "kNumber": "K253643"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "INI (Vehicle, Motorized 3-Wheeled) has three findings, most consequential first. 14 first-time filers in the last 12 months, including Jochu Technology Co., Ltd. and Yongkang Ruihe Metal Product Co., Ltd (K261232, K261163, K253257, K253600, K252813). Clearances are running 42% slower — a median 108 days over the last 12 months against 76 days all-time (elapsed calendar days, not FDA review days) (INI:review_time:12m). The code is crowded, scoring 95 of 100 — 128 companies hold a clearance here and 20 arrived in the last 12 months (INI:crowding).",
    "severity": 50,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "14 first-time filers in the last 12 months, including Jochu Technology Co., Ltd. and Yongkang Ruihe Metal Product Co., Ltd.",
        "recordIds": [
          "K261232",
          "K261163",
          "K253257",
          "K253600",
          "K252813"
        ],
        "severity": 50
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 42% slower — a median 108 days over the last 12 months against 76 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "INI:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 95 of 100 — 128 companies hold a clearance here and 20 arrived in the last 12 months",
        "recordIds": [
          "INI: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%3AINI"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AINI"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AINI"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AINI"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AINI"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AINI"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AINI"
    }
  ],
  "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"
}