FDA device listing
10.5 COMPRESSION KNEE IMMOBILIZER,10 SIGNATURE VINYL WRIST SPLINT L LF,10 SIGNATURE VINYL WRIST SPLINT L RT,10 SIGNATURE…
FDA device listing 1441447546 · Thuasne, LLC
Key facts
| Proprietary names | 10.5 COMPRESSION KNEE IMMOBILIZER,10 SIGNATURE VINYL WRIST SPLINT L LF,10 SIGNATURE VINYL WRIST SPLINT L RT,10 SIGNATURE VINYL WRIST SPLINT M LF,10 SIGNATURE VINYL WRIST SPLINT M RT,10 SIGNATURE VINYL WRIST SPLINT S LF,10 SIGNATURE VINYL WRIST SPLINT S RT,10 SIGNATURE VINYL WRIST SPLINT XL LF,10 SIGNATURE VINYL WRIST SPLINT XL RT,10 ULTRA FIT WRIST SPLINT L LF,10 ULTRA FIT WRIST SPLINT L RT,10… |
|---|---|
| Owner/operator | Thuasne, LLC |
| Owner/operator number | 1218997 |
| 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 | Corflex Caribe, Thuasne, LLC |
| Establishment registrations | 1218997, 3010621943 |
| FEI numbers | 1218997, 3010621943 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Manufacturer, Repackager/Relabeler |
| 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