FDA device listing
Elbow Crutches,Essential,Euro Crutches,Forearm Crutches (GT3003 GT3004T GT3004A GT3004Y GT3004C GT3005T GT3005A GT3005Y…
FDA device listing 1273522623 · ZHONG SHAN YU MIN COMMODITY CO., LTD
Key facts
| Proprietary names | Elbow Crutches,Essential,Euro Crutches,Forearm Crutches (GT3003 GT3004T GT3004A GT3004Y GT3004C GT3005T GT3005A GT3005Y GT3005C),GF,Guardian,Push Button Crutches,RITECARE,Under Arm Crutches (GT1011T GT1011A GT1011Y GT1011C GT1102T GT1102A GT1102Y GT1102C) |
|---|---|
| Owner/operator | ZHONG SHAN YU MIN COMMODITY CO., LTD |
| Owner/operator number | 10091193 |
| Product codes | IPR |
| Device names | IPR - Crutch |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3150 |
| Review panels | Physical Medicine |
| Registered establishments | Com-Bridge International Co., Ltd. |
| Establishment registrations | 3032171543 |
| FEI numbers | 3032171543 |
| 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