{
  "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,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Healium Intelliscan LX192LC"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)"
      ],
      "registration": {
        "registration_number": "3014555455",
        "fei_number": "3014555455",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "Leltek Inc.",
        "address_line_1": "6F.-3, No. 293, Sec. 1, Beixin Rd., Xindian Dist.,",
        "address_line_2": "",
        "city": "New Taipei City",
        "state_code": "",
        "iso_country_code": "TW",
        "zip_code": "",
        "postal_code": "23147",
        "us_agent": {
          "name": "Leigh Kristi",
          "business_name": "",
          "bus_phone_area_code": "410",
          "bus_phone_num": "8149993",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "kleigh@fdaconsultants.com",
          "address_line_1": "2301 Fairhaven Ln",
          "address_line_2": "",
          "city": "Crofton",
          "state_code": "MD",
          "iso_country_code": "US",
          "zip_code": "21114",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "LELTEK",
          "owner_operator_number": "10074230",
          "official_correspondent": {
            "first_name": "RA",
            "middle_initial": "",
            "last_name": "Leltek",
            "subaccount_company_name": "",
            "phone_number": "886-2-29137577-502"
          },
          "contact_address": {
            "address_1": "6F.-3, No. 293, Sec. 1, Beixin Rd., Xindian Dist.,",
            "address_2": "",
            "city": "New Taipei City",
            "state_code": "TW-TPE",
            "state_province": "",
            "iso_country_code": "TW",
            "postal_code": "23147"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "ITX",
          "created_date": "2026-09-03",
          "owner_operator_number": "10074230",
          "exempt": "",
          "openfda": {
            "device_name": "Transducer, Ultrasonic, Diagnostic",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.1570",
            "device_class": "2"
          }
        },
        {
          "product_code": "IYO",
          "created_date": "2026-09-03",
          "owner_operator_number": "10074230",
          "exempt": "",
          "openfda": {
            "device_name": "System, Imaging, Pulsed Echo, Ultrasonic",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.1560",
            "device_class": "2"
          }
        },
        {
          "product_code": "IYN",
          "created_date": "2026-09-03",
          "owner_operator_number": "10074230",
          "exempt": "",
          "openfda": {
            "device_name": "System, Imaging, Pulsed Doppler, Ultrasonic",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.1550",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}