FDA device listing
aerowrap,AeroWrap Compression Foot Wrap Large,AeroWrap Compression Foot Wrap Medium,AeroWrap Compression Foot Wrap…
FDA device listing 1242089151 · Sun-Scientific Inc.
Key facts
| Proprietary names | aerowrap,AeroWrap Compression Foot Wrap Large,AeroWrap Compression Foot Wrap Medium,AeroWrap Compression Foot Wrap Small,AeroWrap full leg compression gaments FL-FL-MLL-L-LF-L,AeroWrap full leg compression gaments FL-FL-MLL-L-LF-M,AeroWrap full leg compression gaments FL-FL-MLL-L-LF-S,AeroWrap full leg compression gaments FL-FL-MLL-L-MF-L,AeroWrap full leg compression gaments… |
|---|---|
| Owner/operator | Sun-Scientific Inc. |
| Owner/operator number | 10034866 |
| Premarket submissions | K070457 |
| Product codes | MHW |
| Device names | MHW - Dressing, Compression |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.5075 |
| Review panels | General Hospital |
| Registered establishments | SUN-SCIENTIFIC INC. |
| Establishment registrations | 3008773774 |
| FEI numbers | 3008773774 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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