FDA device listing
Exoform Dorsal Night Splint,Exoform Knee Immobilizer,Foot-Up,Formfit Ankle with Speedlace,Formfit ROM Knee,Formfit…
FDA device listing 1409217243 · Shenzhen City U-Lucky Sporting Goods Co., Ltd.
Key facts
| Proprietary names | Exoform Dorsal Night Splint,Exoform Knee Immobilizer,Foot-Up,Formfit Ankle with Speedlace,Formfit ROM Knee,Formfit Tracker,Neoprene Hinged Knee Support,Neoprene Knee Sleeve,Neoprene Knee Support with Stabilized Patella,Neoprene Wraparound Hinged Knee Support,Rebound Foot-Up,Rebound Knee,Rebound Knee Immobilizer Universal |
|---|---|
| Owner/operator | Shenzhen City U-Lucky Sporting Goods Co., Ltd. |
| Owner/operator number | 10027287 |
| 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 | SHENZHEN CITY U-LUCKY SPORTING GOODS CO., LTD. |
| Establishment registrations | 3005597706 |
| FEI numbers | 3005597706 |
| Establishment operations | Contract 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