FDA device listing
T2 Active Ankle
FDA device listing 1982529422 · Sum Sporting Goods Works
Key facts
| Proprietary names | T2 Active Ankle |
|---|---|
| Owner/operator | Sum Sporting Goods Works |
| Owner/operator number | 10042430 |
| Product codes | ITW |
| Device names | ITW - Joint, Ankle, External Brace |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | SUM SPORTING GOODS WORKS |
| Establishment registrations | 3010173663 |
| FEI numbers | 3010173663 |
| Establishment operations | Contract Manufacturer, 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