FDA device listing
Sylong Achilles Tendon Rupture Splint (Model:SL-GJ01,SL-GJ02,SL-GJ03,SL-GJ04,SL-GJ05),Sylong Lymphedema Compression Wrap…
FDA device listing 1998146921 · Shenzhen Xilang E-commerce Co., Ltd.
Key facts
| Proprietary names | Sylong Achilles Tendon Rupture Splint (Model:SL-GJ01,SL-GJ02,SL-GJ03,SL-GJ04,SL-GJ05),Sylong Lymphedema Compression Wrap Brace (Model:LB03,SL-LB03,SL-LB04,SL-LB05,SL-LB11,SL-LB12,SL-LB13) |
|---|---|
| Owner/operator | Shenzhen Xilang E-commerce Co., Ltd. |
| Owner/operator number | 10092003 |
| Product codes | ITW |
| Device names | ITW - Joint, Ankle, External Brace |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | SHENZHEN XILANG E-COMMERCE CO., LTD. |
| Establishment registrations | 3034630363 |
| FEI numbers | 3034630363 |
| 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