FDA device listing
Absolute Sleeve,Arm Skinz,Dreamskin,Foam Cover,Footshell,Hand Shell,Natural Definition cosmetic gloves and covers,NEO…
FDA device listing 1760814463 · FILLAUER COMPANIES, INC.
Key facts
| Proprietary names | Absolute Sleeve,Arm Skinz,Dreamskin,Foam Cover,Footshell,Hand Shell,Natural Definition cosmetic gloves and covers,NEO Axilla Loop Padding,Procover |
|---|---|
| Owner/operator | FILLAUER COMPANIES, INC. |
| Owner/operator number | 9910012 |
| Product codes | IPM |
| Device names | IPM - Cover, Limb |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3025 |
| Review panels | Physical Medicine |
| Registered establishments | Fillauer Composites, FILLAUER EUROPE, FILLAUER, LLC |
| Establishment registrations | 1022826, 9681133, 3007510149 |
| FEI numbers | 1022826, 3005564811, 3007510149 |
| 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