FDA device listing
Comfort Cool Hand Splint and Components,Formfit Thumb,Formfit Thumb OA Day,Formfit Universal Thumb,Formfit Universal…
FDA device listing 1401546779 · Shenzhen City U-Lucky Sporting Goods Co., Ltd.
Key facts
| Proprietary names | Comfort Cool Hand Splint and Components,Formfit Thumb,Formfit Thumb OA Day,Formfit Universal Thumb,Formfit Universal Wrist,Formfit Wrist,Norco finger extension tube,Spectra Wrist Brace,Universal Thumb Splint |
|---|---|
| Owner/operator | Shenzhen City U-Lucky Sporting Goods Co., Ltd. |
| Owner/operator number | 10027287 |
| Product codes | ILH |
| Device names | ILH - Splint, Hand, And Components |
| 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 | 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