FDA device listing
Back Brace & Support,Pelvis Support Belt
FDA device listing 1248065652 · Shijiazhuang RUNYI Medical Device Technology Co.,Ltd.
Key facts
| Proprietary names | Back Brace & Support,Pelvis Support Belt |
|---|---|
| Owner/operator | Shijiazhuang RUNYI Medical Device Technology Co.,Ltd. |
| Owner/operator number | 10049499 |
| Product codes | ISR |
| Device names | ISR - Band Or Belt, Pelvic Support |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3025 |
| Review panels | Physical Medicine |
| Registered establishments | SHIJIAZHUANG RUNYI MEDICAL DEVICE TECHNOLOGY CO.,LTD. |
| Establishment registrations | 3011786430 |
| FEI numbers | 3011786430 |
| Establishment operations | 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