FDA device listing
0401 Casual -Medical elastic compression knee-high stockings, closed toe, Class I compression,Articles ELAST 0401 Active…
FDA device listing 1382812236 · SIA Tonus Elast /Tonus Elast, LLC.
Key facts
| Proprietary names | 0401 Casual -Medical elastic compression knee-high stockings, closed toe, Class I compression,Articles ELAST 0401 Active Elastic compression knee stockings for active lifestyle, unisex,Articles ELAST 0401 Business Elastic medical compression knee stockings, with pattern, with toecap,Articles ELAST 0401 Cotton Elastic medical compression knee stockings with toecap, with cotton, unisex,Articles… |
|---|---|
| Owner/operator | SIA Tonus Elast /Tonus Elast, LLC. |
| Owner/operator number | 10057284 |
| Product codes | DWL |
| Device names | DWL - Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5780 |
| Review panels | General Hospital |
| Registered establishments | SIA TONUS ELAST / TONUS ELAST LLC. |
| Establishment registrations | 3011240418 |
| FEI numbers | 3011240418 |
| Establishment operations | Contract Manufacturer, 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