FDA device listing
Manual Wheelchair H008,PCK7
FDA device listing 1986205030 · Jiangsu Yuyue Medical Equipment & Supply Company Limited
Key facts
| Proprietary names | Manual Wheelchair H008,PCK7 |
|---|---|
| Owner/operator | Jiangsu Yuyue Medical Equipment & Supply Company Limited |
| Owner/operator number | 9069200 |
| Premarket submissions | K261571 |
| Product codes | IOR |
| Device names | IOR - Wheelchair, Mechanical |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3850 |
| Review panels | Physical Medicine |
| Registered establishments | Jiangsu Yuyue Medical Equipment & Supply Company Limited |
| Establishment registrations | 3004111085 |
| FEI numbers | 3004111085 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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