DAVID HEALTH SOLUTIONS, LTD.

Registration Details

Registration Name: DAVID HEALTH SOLUTIONS, LTD.
Registration Number: 3016018167
FEI Number: 3016018167
Status: Active
Expiry Year: 2026
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	Device Class	Medical Specialty	Exempt	Created
Interactive Rehabilitation Exercise Device, Prescription Use	QKC	Class 2	Physical Medicine	No	2020-11-06

Proprietary Names

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) EVE WEB Additional Exercises Module G310A Hip Abduction, DMS-EVE, 2,5 / 100 kg, automatic EVE WEB Calendar Modul (Excludes On-Line booking) G420A Lateral Pulldown DMS-EVE 2,5 / 100kg, automatic EVE Professional Terminal (Integrated, For EVE capable machines) EVE WEB Software Service (1-year license) Premium EVE WEB Software Service (1-year license) Basic EVE Printer rack for Info-Kiosk 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) G-160E Cervical Rotation 1 / 25 kg (2.2 / 55 lbs) G-140E Cerv. Extens./Lat. Flexion 1 / 25 kg (2.2 / 55 lbs) EVE WEB Software (Startup Fee) Basic DAVID G310M Hip Abduction 2.5 / 100 kg (5.5 / 220 lbs) G-120E Lumb./Thorac. Rotation 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 EVE WEB Software Service (1-year license) Enterprise EVE WEB Questionnaire Module Exercise Terminal floor mounted G300A Knee Flexion, DMS-EVE, 2,5 / 5 / 150 kg, automatic Exercise Kiosk 42 inch (Floor mounted LCD sccreen)) G250E Elliptic Leg Press, DMS-EVE. 2,5 / 5 / 150 kg G120A Lumb./Thorac. Rotation, DMS-EVE, 2,5 / 100kg, automatic G250A Elliptic Leg Press, DMS-EVE. 2,5 / 5 / 150 kg, automatic EVE Info-Kiosk Central Server with keyboard stand (needs a connection package) G640A Glenohumeral Internal Rotation, DMS-EVE 2,5 / 100kg, automatic EVE Terminal Upgrade (requires return of defect terminal) API Annual Connection fee each additional center - Tier 2 EVE Professional Terminal (Upgrade, includes stands, harware, etc.) G160A Cervical Rotation, DMS-EVE, 1 / 25kg, automatic G140A Cerv. Extens./Lat. Flexion, DMS-EVE, 1 / 25kg, automatic G320A Hip Adduction, DMS-EVE, 2,5 / 100 kg, automatic EVE WIRELESS Connection Package EVE Info-Kiosk Central Server (with a keyboard stand) EVE WEB Software (Startup Fee) Enterprise G300E Knee Flexion 2.5 / 5 / 150 kg (5.5 / 11 / 330 lbs) G-420E Lateral Pulldown 2.5 / 100 kg (5.5 / 220 lbs) G260 Hip Extension 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) G110A Lumb./Thorac. Extension, DMS-EVE, 2,5 / 100kg, automatic G-110E Lumb./Thorac. Extension 2.5 / 100 kG- (5.5 / 220 lbs) G660A Glenohumeral External Rotation, DMS-EVE 2,5 / 100kg, automatic G320M Hip Adduction 2.5 / 100 kg (5.5 / 220 lbs) G130A Lumb./Thorac. Flexion, DMS-EVE, 2,5 / 100kg, automatic API Annual Connection fee for one center - Tier 2 G-130E Lumb./Thorac. Flexion 2.5 / 100 kg (5.5 / 220 lbs) Exercise Kiosk 42 inch (Wall mounted LCD sccreen)) G510A Scapula Protraction/Chest Press DMS-EVE 2,5 / 100 kg automatic G260A Hip Extension DMS-EVE 2,5 / 100 kg, automatic EVE WEB Software (Startup Fee) Premium 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)

Establishment Types

Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198