FDA device listing
ALP 1A Calf Garment,ALP 1 Calf Garment,ALP 1SM Calf Garment,ALP 2 Calf Garment,ALP 2XL Calf Garment,ALP 2XXL Calf…
FDA device listing 1011309727 · Currie Medical, Inc.
Key facts
| Proprietary names | ALP 1A Calf Garment,ALP 1 Calf Garment,ALP 1SM Calf Garment,ALP 2 Calf Garment,ALP 2XL Calf Garment,ALP 2XXL Calf Garment,ALP 3SM Thigh Garment,ALP 3 Thigh Garment,ALP 4 Thigh Garment,ALP 4XL Calf Garment,ALP 501 Pump System |
|---|---|
| Owner/operator | Currie Medical, Inc. |
| Owner/operator number | 10085857 |
| Premarket submissions | K955853 |
| Product codes | JOW |
| Device names | JOW - Sleeve, Limb, Compressible |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.5800 |
| Review panels | Cardiovascular |
| Registered establishments | Currie Medical, Inc. |
| Establishment registrations | 3013659199 |
| FEI numbers | 3013659199 |
| Establishment operations | Reprocessor of Single Use Devices, Specification Developer |
| 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