FDA device listing
Arm Sleeves,Fracture/Brace Sock,Post-op Socks,Super Sheath,The Royal Double Fleeces & 1-Ply Underliner Sock,The Royal…
FDA device listing 1863030398 · Royal Knit Inc.
Key facts
| Proprietary names | Arm Sleeves,Fracture/Brace Sock,Post-op Socks,Super Sheath,The Royal Double Fleeces & 1-Ply Underliner Sock,The Royal Flush,The Royal Knit Cranial Cap,The Royal Orthotic Brace Sock,Torso Body Sock |
|---|---|
| Owner/operator | Royal Knit Inc. |
| Owner/operator number | 10080339 |
| Product codes | IPM |
| Device names | IPM - Cover, Limb |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3025 |
| Review panels | Physical Medicine |
| Registered establishments | ROYAL KNIT INC. |
| Establishment registrations | 3005276041 |
| FEI numbers | 3005276041 |
| Establishment operations | 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