FDA device listing
844 Ankle Sleeve with Compression Fit,845 Ankle Sleeve with Compression Wrap Support,847 Ankle Stabilizer with Flexible…
FDA device listing 1209863245 · Tu Yu Sports instrument factory
Key facts
| Proprietary names | 844 Ankle Sleeve with Compression Fit,845 Ankle Sleeve with Compression Wrap Support,847 Ankle Stabilizer with Flexible Support Stays,849 Ultra Gel Lace Ankle Support,851 Ultra Wrap Lace Ankle Support,854 V-Flex Ankle Brace,855 V-Flex Ankle XT Brace,889 Ankle Brace Compression Cover,891 Sonic Ankle Support,894 Sonic Ankle Brace w/ Flex-Support Stays and Figure 8 Straps,896 Laceless Cleat Ankle… |
|---|---|
| Owner/operator | Tu Yu Sports instrument factory |
| Owner/operator number | 10041441 |
| 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 | Praegear Viet Nam Co., Ltd. |
| Establishment registrations | 3014947080 |
| FEI numbers | 3014947080 |
| 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