{
  "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": "2026-10-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Bone conduction hearing aid"
      ],
      "establishment_type": [
        "Complaint File Establishment per 21 CFR 820.198",
        "Develop Specifications But Do Not Manufacture At This Facility",
        "Export Device to the United States But Perform No Other Operation on Device"
      ],
      "registration": {
        "registration_number": "3049809193",
        "fei_number": "3049809193",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2027",
        "name": "SHOKZ HEALTH GLOBAL LIMITED",
        "address_line_1": "ROOM 708, 7TH FLOOR, HANG SENG CASTLE PEAK ROAD BUILDING",
        "address_line_2": "339 CASTLE PEAK ROAD, CHEUNG SHA WAN",
        "city": "KOWLOON",
        "state_code": "",
        "iso_country_code": "HK",
        "zip_code": "",
        "postal_code": "000000",
        "us_agent": {
          "name": "Nick Bilge",
          "business_name": "",
          "bus_phone_area_code": "585",
          "bus_phone_num": "2782934",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "Nbilge@shokz.com",
          "address_line_1": "3200 Gracie Kiltz Ln Ste 300",
          "address_line_2": "",
          "city": "Austin",
          "state_code": "TX",
          "iso_country_code": "US",
          "zip_code": "78758",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Shokz Health Global Limited",
          "owner_operator_number": "10096337",
          "official_correspondent": {
            "first_name": "Glen",
            "middle_initial": "",
            "last_name": "Zeng",
            "subaccount_company_name": "",
            "phone_number": "86-0755-83937200-x"
          },
          "contact_address": {
            "address_1": "Langxin Community, Shiyan Street, Bao'an District, Shenzhen, Guangdong, China.",
            "address_2": "",
            "city": "Shenzhen",
            "state_code": "CN-GD",
            "state_province": "Guangdong",
            "iso_country_code": "CN",
            "postal_code": "518000"
          }
        }
      },
      "pma_number": "",
      "k_number": "K253431",
      "products": [
        {
          "product_code": "LXB",
          "created_date": "2026-09-11",
          "owner_operator_number": "10096337",
          "exempt": "",
          "openfda": {
            "k_number": [
              "K253431"
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            "device_name": "Hearing Aid, Bone Conduction",
            "medical_specialty_description": "Ear, Nose, Throat",
            "regulation_number": "874.3302",
            "device_class": "2"
          }
        }
      ]
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}