FDA device listing
Orthosis, Limb Brace
FDA device listing 1965506693 · Dongguan City Fenglinwan Leisure Products Co., Ltd.
Key facts
| Owner/operator | Dongguan City Fenglinwan Leisure Products Co., Ltd. |
|---|---|
| Owner/operator number | 10082297 |
| 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 | DONGGUAN CITY FENGLINWAN LEISURE PRODUCTS CO., LTD. |
| Establishment registrations | 3020282968 |
| FEI numbers | 3020282968 |
| Establishment operations | Contract Manufacturer, 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