{
  "format": "devicerts.device.v1",
  "cite_as": "Mobility Scooter W3331F, Zhejiang Innuovo Rehabilitation Devices Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/mobility-scooter-model-w3331f-ini (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/mobility-scooter-model-w3331f-ini",
    "json_url": "https://devicerts.com/devices/mobility-scooter-model-w3331f-ini.json",
    "markdown_url": "https://devicerts.com/devices/mobility-scooter-model-w3331f-ini.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-11-08",
    "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/devices/mobility-scooter-model-w3331f-ini",
    "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."
  },
  "device": {
    "name": "Mobility Scooter W3331F",
    "registry_name": "Mobility Scooter, Model: W3331F",
    "url": "https://devicerts.com/devices/mobility-scooter-model-w3331f-ini",
    "manufacturer": {
      "name": "Zhejiang Innuovo Rehabilitation Devices Co., Ltd.",
      "url": "https://devicerts.com/manufacturers/zhejiang-innuovo-rehabilitation-devices-coltd",
      "country": "China",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
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    "identifiers": [
      {
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        "values": [
          {
            "value": "K222495",
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        ]
      }
    ],
    "product_codes": [
      "INI"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Mobility Scooter W3331F is a motorized three-wheeled vehicle designed for individuals with limited mobility. It assists users in indoor and outdoor environments by providing powered propulsion, enabling independent movement over short to moderate distances. The device is classified as a Class II medical device under FDA regulations, intended for personal transport and mobility support.\n\nThis mobility scooter is supplied as a reusable device, intended for long-term use by individuals requiring assistance with ambulation. It is not sterile and is not intended for MRI environments. The W3331F model is regulated under 21 CFR 890.3800 and received FDA 510(k) clearance (K222495) as substantially equivalent to predicate devices. Storage and maintenance instructions are provided by the manufacturer to ensure safe and effective operation.",
      "ai_generated": true,
      "generated_on": "2026-10-01",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K222495",
      "number_label": null,
      "device_udi_di": null,
      "date": "2022-10-17",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
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}