FDA device listing
Bio-Logix Knee Brace Multi-Sport Sleeve,Bio-Logix Knee Brace Padded Sleeve,Bio-Logix Knee Brace Patella Support…
FDA device listing 1204544140 · Tu Yu Sports instrument factory
Key facts
| Proprietary names | Bio-Logix Knee Brace Multi-Sport Sleeve,Bio-Logix Knee Brace Padded Sleeve,Bio-Logix Knee Brace Patella Support Sleeve,Universal Knee Brace Sleeve,Universal Knee Brace Sleeve w/ Hex Pad |
|---|---|
| Owner/operator | Tu Yu Sports instrument factory |
| Owner/operator number | 10041441 |
| Product codes | IPM |
| Device names | IPM - Cover, Limb |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3025 |
| 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