FDA device listing
AXR-2000 Pressure Management Foam Wedge,Azul ITPW,CHST-3000 Chest Pad and Chest Strap Accessory Kit,FPLS-3000-Wing,ION…
FDA device listing 1887933417 · Infinitus Medical Technologies LLC
Key facts
| Proprietary names | AXR-2000 Pressure Management Foam Wedge,Azul ITPW,CHST-3000 Chest Pad and Chest Strap Accessory Kit,FPLS-3000-Wing,ION ESPS Foam insert,LUNA Supine Pad SP-3500,Mizuho Hana Table Pad and Strap PN FPLS-1210SP,Pneuma Genesis Bi-Wing AAP Inflatable Assist Positioning System,Pneuma Hadron FPLS (inflatable assist positioning system),The Genesis Bi-Wing AAP arm adduction pad,The Hadron FPLS Foam Pad Lift… |
|---|---|
| Owner/operator | Infinitus Medical Technologies LLC |
| Owner/operator number | 10044733 |
| Product codes | CCX |
| Device names | CCX - Support, Patient Position |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.6820 |
| Review panels | Anesthesiology |
| Registered establishments | INFINITUS MEDICAL TECHNOLOGIES LLC |
| Establishment registrations | 3010396722 |
| FEI numbers | 3010396722 |
| Establishment operations | Contract Manufacturer, Specification Developer |
| 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