{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-07",
    "results": {
      "skip": 0,
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  "results": [
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      "proprietary_name": [
        "JOINT, ANKLE, EXTERNAL BRACE"
      ],
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        "Manufacture Medical Device for Another Party (Contract Manufacturer)"
      ],
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        "registration_number": "3007125287",
        "fei_number": "3007125287",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "OCEAN WELL CO., LTD.",
        "address_line_1": "Rm. 201, Building 1, No. 38, Baihao Industry St., Houjie Town,",
        "address_line_2": "Dongguan City, Guangdong, China",
        "city": "Dongguan Guangdong",
        "state_code": "",
        "iso_country_code": "CN",
        "zip_code": "",
        "postal_code": "523957",
        "us_agent": {
          "name": "Mark Cooper",
          "business_name": "Darco International Inc.",
          "bus_phone_area_code": "304",
          "bus_phone_num": "5224883",
          "bus_phone_extn": "",
          "fax_area_code": "304",
          "fax_num": "5220038",
          "email_address": "mcooper@darcointernational.com",
          "address_line_1": "810 Memorial Blvd. Huntington",
          "address_line_2": "",
          "city": "Huntington",
          "state_code": "WV",
          "iso_country_code": "US",
          "zip_code": "25701",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Ocean Well Co., Ltd.",
          "owner_operator_number": "10026765",
          "official_correspondent": {
            "first_name": "James",
            "middle_initial": "",
            "last_name": "Chang",
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            "phone_number": "86-769-85815436-x"
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            "address_2": "",
            "city": "Dongguan",
            "state_code": "CN-GD",
            "state_province": "Guangdong",
            "iso_country_code": "CN",
            "postal_code": "523955"
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        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
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          "product_code": "ITW",
          "created_date": "2017-04-12",
          "owner_operator_number": "10026765",
          "exempt": "",
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            "device_name": "Joint, Ankle, External Brace",
            "medical_specialty_description": "Physical Medicine",
            "regulation_number": "890.3475",
            "device_class": "1"
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}