FDA Device Establishments · JSON-LD · Markdown
FEI 3016018167 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3016018167 |
|---|---|
| Owner / Operator | David Health Solutions, Ltd. (#10078834) |
| Address | Tutkijankatu 2, Outokumpu Pohjois-Karjala, 83500, FI |
| Mandatory US Agent | David Health. LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | QKC |
| Regulation § (21 CFR) | 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. Public-domain (CC0).