# DAVID HEALTH SOLUTIONS, LTD.

FEI: 3016018167
Status: Active
Establishment types: Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Owner/operator: David Health Solutions, Ltd. (#10078834)

Address: Tutkijankatu 2, Outokumpu Pohjois-Karjala, 83500, FI

Mandatory US Agent: David Health. LLC

## Products

Total registered: 1
Top product codes: QKC
Regulation §: 890.5360

Proprietary names: EVE WEB Software (Startup Fee) Premium, 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), G110A Lumb./Thorac. Extension, DMS-EVE, 2,5 / 100kg, automatic, EVE Info-Kiosk Central Server (with a keyboard stand), G510A Scapula Protraction/Chest Press DMS-EVE 2,5 / 100 kg automatic, G130A Lumb./Thorac. Flexion, DMS-EVE, 2,5 / 100kg, automatic, G300A Knee Flexion, DMS-EVE, 2,5 / 5 / 150 kg, automatic, G160A Cervical Rotation, DMS-EVE, 1 / 25kg, automatic, G310A Hip Abduction, DMS-EVE, 2,5 / 100 kg, automatic

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223016018167%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3016018167