FDA device listing
SHOULDER SLINGS, Kangaroo Shoulder Sling KSS001,Kahuna Brace KB001,Mini Kahuna Brace MKB001
FDA device listing 1464740257 · XIAMEN ORTOCARE SPORTS HEALTH CO.,LTD.
Key facts
| Proprietary names | SHOULDER SLINGS, Kangaroo Shoulder Sling KSS001,Kahuna Brace KB001,Mini Kahuna Brace MKB001 |
|---|---|
| Owner/operator | XIAMEN ORTOCARE SPORTS HEALTH CO.,LTD. |
| Owner/operator number | 10056512 |
| Product codes | ILE |
| Device names | ILE - Sling, Arm, Overhead Supported |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | XIAMEN ORTOCARE SPORTS HEALTH CO.,LTD. |
| Establishment registrations | 3012841710 |
| FEI numbers | 3012841710 |
| Establishment operations | Contract 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