FDA device listing
Foot Brace Shoe
FDA device listing 1214969038 · TIEN JIANG ENTERPRISE CO., LTD.
Key facts
| Proprietary names | Foot Brace Shoe |
|---|---|
| Owner/operator | TIEN JIANG ENTERPRISE CO., LTD. |
| Owner/operator number | 9056877 |
| Product codes | OHI |
| Device names | OHI - Orthosis, Foot Drop |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | DONGGUAN NAN YOU SPORTING GOODS ENTERPRISE LTD, LIANG CHENG SPORTING GOODS COMPANY LIMITED, TIEN JIANG ENTERPRISE CO., LTD. |
| Establishment registrations | 3003849847, 3005621301, 3010508273 |
| FEI numbers | 3003849847, 3005621301, 3010508273 |
| Establishment operations | Contract Manufacturer, 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