FDA device listing
Action Reliever,Active Reliever,Air Townsend,Air Townsend Reliever,Argicalm Th Sport,Bold,Compression Calf…
FDA device listing 1108386759 · Thuasne S.A.S.
Key facts
| Proprietary names | Action Reliever,Active Reliever,Air Townsend,Air Townsend Reliever,Argicalm Th Sport,Bold,Compression Calf Sleeves,Compression Socks,Dynamic KAFO,Dynamic Reliever,ExoGuard,Full Shell,Full Shell BK,Full Shell KAFO,Genu Dynastab,Genuextrem,Genu Ligaflex,Genu Ligaflex ROM,Genu Pro Activ,Genu ProMaster,GenuStart,GenuStart ROM,Ligastrap Genu,Motocross Series,Patella Reliever,PR1,Premier,Premier… |
|---|---|
| Owner/operator | Thuasne S.A.S. |
| Owner/operator number | 10094514 |
| Product codes | IQI |
| Device names | IQI - Orthosis, Limb Brace |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | Textile Medicale, THUASNE DEUTSCHLAND GMBH, THUASNE SAS |
| Establishment registrations | 8010658, 3009591332, 3011678115 |
| FEI numbers | 4368, 3009591332, 3011678115 |
| Establishment operations | 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