{
  "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": {
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  "results": [
    {
      "proprietary_name": [
        "G-140E Cerv. Extens./Lat. Flexion 1 / 25 kg (2.2 / 55 lbs)",
        "EVE WEB Software (Startup Fee) Basic",
        "EVE Professional Terminal (Integrated, For EVE capable machines)",
        "Exercise Kiosk 42 inch (Wall mounted LCD sccreen))",
        "G-420E Lateral Pulldown 2.5 / 100 kg (5.5 / 220 lbs)",
        "G260 Hip Extension 2.5 / 100 kg (5.5 / 220 lbs)",
        "EVE WIRELESS Connection Package",
        "EVE Info-Kiosk Central Server (with a keyboard stand)",
        "G420A Lateral Pulldown DMS-EVE 2,5 / 100kg, automatic",
        "G140A Cerv. Extens./Lat. Flexion, DMS-EVE, 1 / 25kg, automatic",
        "EVE WEB Software (Startup Fee) Premium",
        "G-460E Diagonal Shoulder Abduction 2.5 / 100 kg (5.5 / 220 lbs)",
        "G300E Knee Flexion 2.5 / 5 / 150 kg (5.5 / 11 / 330 lbs)",
        "EVE WEB Software Service (1-year license) Premium",
        "G510A Scapula Protraction/Chest Press DMS-EVE 2,5 / 100 kg automatic",
        "G260A Hip Extension DMS-EVE 2,5 / 100 kg, automatic",
        "G310A Hip Abduction, DMS-EVE, 2,5 / 100 kg, automatic",
        "EVE WEB Calendar Modul (Excludes On-Line booking)",
        "G300A Knee Flexion, DMS-EVE, 2,5 / 5 / 150 kg, automatic",
        "EVE Printer rack for Info-Kiosk",
        "EVE WEB Software (Startup Fee) Enterprise",
        "G120A Lumb./Thorac. Rotation, DMS-EVE, 2,5 / 100kg, automatic",
        "G-110E Lumb./Thorac. Extension 2.5 / 100 kG- (5.5 / 220 lbs)",
        "G-510E Scapula Protraction/Chest Press 2.5 / 100 kg (5.5 / 220 lbs)",
        "G200E Knee Extension 2.5 / 5 / 150 kg (5.5 / 11 / 330 lbs)",
        "G320M Hip Adduction 2.5 / 100 kg (5.5 / 220 lbs)",
        "G200A Knee Extension, DMS-EVE. 2,5 / 5 / 150 kg, automatic",
        "G150A Lumb./Thorac. Lat. Flex., DMS-EVE, 2,5 / 100kg, automatic",
        "API Annual Connection fee for one center - Tier 2",
        "G320A Hip Adduction, DMS-EVE, 2,5 / 100 kg, automatic",
        "G660A Glenohumeral External  Rotation,  DMS-EVE 2,5 / 100kg, automatic",
        "EVE  WEB Software device fee (per device per year - required for all SAAS installations)",
        "EVE WEB Software Service (1-year license) Enterprise",
        "EVE WEB Software Service (1-year license) Basic",
        "G-160E Cervical Rotation 1 / 25 kg (2.2 / 55 lbs)",
        "Exercise Terminal floor mounted",
        "EVE Terminal Upgrade (requires return of defect terminal)",
        "G130A Lumb./Thorac. Flexion, DMS-EVE, 2,5 / 100kg, automatic",
        "DAVID",
        "EVE WEB Questionnaire Module",
        "G310M Hip Abduction 2.5 / 100 kg (5.5 / 220 lbs)",
        "API Annual Connection fee each additional center - Tier 2",
        "G110A Lumb./Thorac. Extension, DMS-EVE, 2,5 / 100kg, automatic",
        "G-150E Lumb./Thorac. Lat. Flexion 2.5 / 100 kg (5.5 / 220 lbs)",
        "G-660E Glenohumeral External  Rotation 2.5 / 100 kg (5.5 / 220 lbs)",
        "Exercise Kiosk 42 inch (Floor mounted LCD sccreen))",
        "G250E Elliptic Leg Press, DMS-EVE. 2,5 / 5 / 150 kg",
        "G-130E Lumb./Thorac. Flexion 2.5 / 100 kg (5.5 / 220 lbs)",
        "G-120E Lumb./Thorac. Rotation 2.5 / 100 kG- (5.5 / 220 lbs)",
        "G460A Diagonal Shoulder Abduction, DMS-EVE 2,5 / 100kg, automatic",
        "G-640E Glenohumeral Internal Rotation 2.5 / 100 kg (5.5 / 220 lbs)",
        "G640A Glenohumeral Internal Rotation,  DMS-EVE 2,5 / 100kg, automatic",
        "EVE Professional Terminal (Upgrade, includes stands, harware, etc.)",
        "G160A Cervical Rotation, DMS-EVE, 1 / 25kg, automatic",
        "EVE WEB Additional Exercises Module",
        "G250A Elliptic Leg Press, DMS-EVE. 2,5 / 5 / 150 kg, automatic",
        "EVE Info-Kiosk Central Server with keyboard stand (needs a connection package)"
      ],
      "establishment_type": [
        "Complaint File Establishment per 21 CFR 820.198",
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3016018167",
        "fei_number": "3016018167",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "DAVID HEALTH SOLUTIONS, LTD.",
        "address_line_1": "Tutkijankatu 2",
        "address_line_2": "",
        "city": "Outokumpu Pohjois-Karjala",
        "state_code": "",
        "iso_country_code": "FI",
        "zip_code": "",
        "postal_code": "83500",
        "us_agent": {
          "name": "Matti Jarvinen",
          "business_name": "David Health. LLC",
          "bus_phone_area_code": "720",
          "bus_phone_num": "2017207",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "andy.jarvinen@davidhealth.com",
          "address_line_1": "8484 Greenwood Dr",
          "address_line_2": "",
          "city": "Niwot",
          "state_code": "CO",
          "iso_country_code": "US",
          "zip_code": "80503",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "David Health Solutions, Ltd.",
          "owner_operator_number": "10078834",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "Tutkijankatu 2",
            "address_2": "",
            "city": "Outokumpu",
            "state_code": "FI-13",
            "state_province": "Pohjois-Karjala",
            "iso_country_code": "FI",
            "postal_code": "83500"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "QKC",
          "created_date": "2020-11-06",
          "owner_operator_number": "10078834",
          "exempt": "",
          "openfda": {
            "device_name": "Interactive Rehabilitation Exercise Device, Prescription Use",
            "medical_specialty_description": "Physical Medicine",
            "regulation_number": "890.5360",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}