FDA device listing
Alps,Alps Coolfit Brace,Alps Knee Brace,Alps Knee Brace Wraparound,Alps South LLC
FDA device listing 1820226007 · ALPS SOUTH LLC
Key facts
| Proprietary names | Alps,Alps Coolfit Brace,Alps Knee Brace,Alps Knee Brace Wraparound,Alps South LLC |
|---|---|
| Owner/operator | ALPS SOUTH LLC |
| Owner/operator number | 9010103 |
| 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 | ALPS SOUTH LLC, ALPS XIANGTAN PROSTHETIC & ORTHOTIC CO., LTD. |
| Establishment registrations | 1058063, 3005695806 |
| FEI numbers | 1000222175, 3005695806 |
| Establishment operations | 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