FDA device listing
Calf thigh DVT,dvt sleeve
FDA device listing 1611159790 · SHANGHAI GAOHUI RUBBER AND PLASTIC PRODUCTS CO., LTD
Key facts
| Proprietary names | Calf thigh DVT,dvt sleeve |
|---|---|
| Owner/operator | SHANGHAI GAOHUI RUBBER AND PLASTIC PRODUCTS CO., LTD |
| Owner/operator number | 10032286 |
| Product codes | IQI |
| Device names | IQI - Orthosis, Limb Brace |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | SHANGHAI GAOHUI RUBBER AND PLASTIC PRODUCTS CO., LTD |
| Establishment registrations | 3008381116 |
| FEI numbers | 3008381116 |
| 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