FDA device listing
Action Reliever,Genu Dynastab,GenuExtrem,Genu-Go Silistab,Genu Ligaflex,Genu Ligaflex ROM,Genu Pro Activ,Genu…
FDA device listing 1361643544 · Thuasne S.A.S.
Key facts
| Proprietary names | Action Reliever,Genu Dynastab,GenuExtrem,Genu-Go Silistab,Genu Ligaflex,Genu Ligaflex ROM,Genu Pro Activ,Genu Promaster,Knee Brace Action Reliever,Knee Brace Genu Action,Knee Brace Genu Dynastab,Knee Brace Genuextrem,Knee Brace Genu Ligaflex Long,Knee Brace Genu Ligaflex Long Open,Knee Brace Genu Ligaflex ROM,Knee Brace Genu Ligaflex Short,Knee Brace Genu Ligaflex Short Open,Knee Brace Genu Pro… |
|---|---|
| Owner/operator | Thuasne S.A.S. |
| Owner/operator number | 10094514 |
| Product codes | ITQ |
| Device names | ITQ - Joint, Knee, External Brace |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | Textile Medicale, Thuasne Czech Republic S.R.O, THUASNE DEUTSCHLAND GMBH, THUASNE SAS |
| Establishment registrations | 8010658, 3009591332, 3011678115, 3012027699 |
| FEI numbers | 4368, 3009591332, 3011678115, 3012027699 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database