{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Whill, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/whill-inc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/whill-inc",
    "json_url": "https://devicerts.com/manufacturers/whill-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/whill-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA registration and listing",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "eudamed_record_synced": "2026-11-07",
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-14",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/manufacturers/whill-inc",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "manufacturer": {
    "name": "Whill, Inc.",
    "url": "https://devicerts.com/manufacturers/whill-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "Japan",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "JP-MF-000016481"
      },
      {
        "label": "FDA FEI",
        "value": "3021071770"
      },
      {
        "label": "DUNS",
        "value": "691746455"
      }
    ],
    "summary": "Whill, Inc. is a medical device manufacturer based in Japan, with 11 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class I; FDA Class II) and 2 FDA recalls as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 11,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 2,
    "fda_recalls_ongoing": 2,
    "fda_recalls_ongoing_recent": 2,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "EUDAMED",
        "devices": 6
      },
      {
        "registry": "FDA GUDID",
        "devices": 4
      },
      {
        "registry": "FDA 510(k)",
        "devices": 2
      }
    ],
    "device_classes": [
      {
        "class": "EU Class I",
        "devices": 6
      },
      {
        "class": "FDA Class II",
        "devices": 5
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Y12",
        "name": "Personal mobility devices",
        "url": "https://devicerts.com/categories/emdn/Y12",
        "devices": 6
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "CMC Medical Devices & Drugs SL",
        "url": "https://devicerts.com/representatives/cmc-medical-devices-drugs-sl-es-ar-000000293",
        "country": "Spain"
      }
    ]
  },
  "devices": {
    "shown": 11,
    "total": 11,
    "all_devices_url": "https://devicerts.com/manufacturers/whill-inc",
    "items": [
      {
        "name": "WHILL (WHILL Model C2)",
        "url": "https://devicerts.com/devices/whill-whill-model-c2-iti",
        "model_reference": "K261175",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2026-06-12",
        "open_recall": false
      },
      {
        "name": "WHILL Model R 4-wheel",
        "url": "https://devicerts.com/devices/whill-model-r-4-wheel-32-21014-1-03-2025-0",
        "model_reference": "32-21014-1-03-2025-02-28",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "WHILL, Inc. Model C2",
        "url": "https://devicerts.com/devices/whill-inc-32-00022-j-02-2024-0-a47bedc5",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      },
      {
        "name": "WHILL, Inc. Model C2",
        "url": "https://devicerts.com/devices/whill-inc-32-00022-j-02-2024-0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      },
      {
        "name": "WHILL Model M",
        "url": "https://devicerts.com/devices/whill-model-m",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "WHILL Model C Lite",
        "url": "https://devicerts.com/devices/whill-model-c-lite-32-15018-1-01-2026-0",
        "model_reference": "32-15018-1-01-2026-03-06",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "WHILL Model F",
        "url": "https://devicerts.com/devices/whill-model-c2-whill-model-f-whill-model-ff-whill-model-r-3-32-14016-1-04-2024-0",
        "model_reference": "32-14016-1-04-2024-02-15",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "WHILL Model M",
        "url": "https://devicerts.com/devices/whill-model-m-iti",
        "model_reference": "K153543",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2016-02-12",
        "open_recall": false
      },
      {
        "name": "WHILL Model R 3-wheel",
        "url": "https://devicerts.com/devices/whill-model-r-32-21014-1-03-2025-0",
        "model_reference": "32-21014-1-03-2025-02-28",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "WHILL Autonomous Model B",
        "url": "https://devicerts.com/devices/whill-autonomous-model-b-32-18010-0-01-2024-0",
        "model_reference": "32-18010-0-01-2024-07-15",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "WHILL Model C2",
        "url": "https://devicerts.com/devices/whill-model-c2-whill-model-f-whill-model-ff-whill-model-r-3-32-00022-j-02-2024-0-f605d6d8",
        "model_reference": "32-00022-J-02-2024-02-15",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      }
    ]
  },
  "certificates": [],
  "recalls": [
    {
      "number": "Z-1826-2026",
      "classification": "Class I",
      "status": "Ongoing",
      "initiated": "2025-12-29",
      "product_code": "ITI",
      "reason": "Cyber vulnerability of BLE communication was found by CISA VDP program."
    },
    {
      "number": "Z-1827-2026",
      "classification": "Class I",
      "status": "Ongoing",
      "initiated": "2025-12-29",
      "product_code": "ITI",
      "reason": "Cyber vulnerability of BLE communication was found by CISA VDP program."
    }
  ]
}
