BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    EVE WEB Software Service (1-year license) Premium

    Reg #: 3016018167 · FEI: 3016018167 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    57
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DAVID HEALTH SOLUTIONS, LTD.
    Registration Number
    3016018167
    FEI Number
    3016018167
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Tutkijankatu 2
    City
    Outokumpu Pohjois-Karjala
    Country
    FI

    Owner / Operator

    Firm Name
    David Health Solutions, Ltd.
    Operator Number
    10078834
    Address
    Tutkijankatu 2
    City
    Outokumpu
    State
    Pohjois-Karjala
    Postal Code
    83500
    Country
    FI

    US Agent

    Business Name
    David Health. LLC
    Contact Name
    Matti Jarvinen
    Address
    8484 Greenwood Dr
    City
    Niwot
    State
    CO
    ZIP
    80503
    Country
    US
    Email
    [email protected]
    Phone
    720 2017207

    Products

    Device Name Product Code
    Interactive Rehabilitation Exercise Device, Prescription Use QKC

    Proprietary Names

    EVE WEB Software Service (1-year license) Premium G-160E Cervical Rotation 1 / 25 kg (2.2 / 55 lbs) Exercise Terminal floor mounted 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) G300A Knee Flexion, DMS-EVE, 2,5 / 5 / 150 kg, automatic EVE Professional Terminal (Upgrade, includes stands, harware, etc.) G-640E Glenohumeral Internal Rotation 2.5 / 100 kg (5.5 / 220 lbs) G250A Elliptic Leg Press, DMS-EVE. 2,5 / 5 / 150 kg, automatic G150A Lumb./Thorac. Lat. Flex., DMS-EVE, 2,5 / 100kg, automatic EVE Terminal Upgrade (requires return of defect terminal) G160A Cervical Rotation, DMS-EVE, 1 / 25kg, automatic G260 Hip Extension 2.5 / 100 kg (5.5 / 220 lbs) G420A Lateral Pulldown DMS-EVE 2,5 / 100kg, automatic Exercise Kiosk 42 inch (Wall mounted LCD sccreen)) EVE WEB Software (Startup Fee) Premium G200A Knee Extension, DMS-EVE. 2,5 / 5 / 150 kg, automatic G640A Glenohumeral Internal Rotation, DMS-EVE 2,5 / 100kg, automatic EVE Info-Kiosk Central Server (with a keyboard stand) EVE Info-Kiosk Central Server with keyboard stand (needs a connection package) G120A Lumb./Thorac. Rotation, DMS-EVE, 2,5 / 100kg, automatic API Annual Connection fee for one center - Tier 2 G250E Elliptic Leg Press, DMS-EVE. 2,5 / 5 / 150 kg G660A Glenohumeral External Rotation, DMS-EVE 2,5 / 100kg, automatic EVE Professional Terminal (Integrated, For EVE capable machines) API Annual Connection fee each additional center - Tier 2 EVE WEB Software (Startup Fee) Enterprise G460A Diagonal Shoulder Abduction, DMS-EVE 2,5 / 100kg, automatic G110A Lumb./Thorac. Extension, DMS-EVE, 2,5 / 100kg, automatic EVE WIRELESS Connection Package G510A Scapula Protraction/Chest Press DMS-EVE 2,5 / 100 kg automatic G260A Hip Extension DMS-EVE 2,5 / 100 kg, automatic G130A Lumb./Thorac. Flexion, DMS-EVE, 2,5 / 100kg, automatic G-140E Cerv. Extens./Lat. Flexion 1 / 25 kg (2.2 / 55 lbs) G140A Cerv. Extens./Lat. Flexion, DMS-EVE, 1 / 25kg, automatic G-150E Lumb./Thorac. Lat. Flexion 2.5 / 100 kg (5.5 / 220 lbs) Exercise Kiosk 42 inch (Floor mounted LCD sccreen)) G-110E Lumb./Thorac. Extension 2.5 / 100 kG- (5.5 / 220 lbs) EVE WEB Software Service (1-year license) Enterprise G-420E Lateral Pulldown 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) DAVID EVE WEB Software device fee (per device per year - required for all SAAS installations) 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 Additional Exercises Module EVE WEB Questionnaire Module G310M Hip Abduction 2.5 / 100 kg (5.5 / 220 lbs) EVE WEB Software (Startup Fee) Basic EVE WEB Software Service (1-year license) Basic G320A Hip Adduction, 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) EVE Printer rack for Info-Kiosk G-660E Glenohumeral External Rotation 2.5 / 100 kg (5.5 / 220 lbs)

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198