FDA device listing
Custom Elbow Brace,Digiband,Dynastab Dual,Elbow Brace Epimed,Elbow Brace Silistab Epi,Epimed,EpiMed Promaster,Epi…
FDA device listing 1692797568 · Thuasne S.A.S.
Key facts
| Proprietary names | Custom Elbow Brace,Digiband,Dynastab Dual,Elbow Brace Epimed,Elbow Brace Silistab Epi,Epimed,EpiMed Promaster,Epi ProMaster,Functional Elbow Brace,Knitted Elbow Sleeve,LigaFlex Action,Ligaflex Boxer,Ligaflex Classic Open,Ligaflex Finger,Ligaflex Immo,Ligaflex Manu,LigaFlex Pro,LigaFlex Pro Plus,Ligaflex Rhizo,Manu GO,Manuimmo Junior,Manu ProMaster,Manurhizo Formit,Manurhizo Junior,Rhizo Pro,ROM… |
|---|---|
| Owner/operator | Thuasne S.A.S. |
| Owner/operator number | 10094514 |
| Product codes | IOY |
| Device names | IOY - Support, Arm |
| 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