FDA device listing
Coolblue Prosthetic Sock,KCM-H-BUNDLE - Coolmax Sock Medium w/Hole Bundle,KCM-H - Coolmax Sock Medium…
FDA device listing 1075577518 · ALPS SOUTH LLC
Key facts
| Proprietary names | Coolblue Prosthetic Sock,KCM-H-BUNDLE - Coolmax Sock Medium w/Hole Bundle,KCM-H - Coolmax Sock Medium w/Hole,KCM-HR-BUNDLE - Coolmax Sock Medium w/Plastic Bundle,KCM-HR - Coolmax Sock Medium w/Plastic,KCM-N-BUNDLE - Coolmax Sock Medium w/o Hole Bundle,KCM-N - Coomax Sock Medium w/o Hole,KCMPL-H-BUNDLE - Private Label Coolmax Sock Medium w/Hole Bundle,KCMPL-HR-BUNDLE - Private Label Coolmax Sock… |
|---|---|
| Owner/operator | ALPS SOUTH LLC |
| Owner/operator number | 9010103 |
| Product codes | IPM |
| Device names | IPM - Cover, Limb |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3025 |
| Review panels | Physical Medicine |
| Registered establishments | ALPS SOUTH LLC |
| Establishment registrations | 1058063 |
| FEI numbers | 1000222175 |
| 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