FDA device listing
Accora AX7IM serial Anti-decubitus air pump & air mattress system,Accora AX7 serial Anti-decubitus air pump & air…
FDA device listing 1151463382 · Sequoia-TWN Healthcare co. Ltd.
Key facts
| Proprietary names | Accora AX7IM serial Anti-decubitus air pump & air mattress system,Accora AX7 serial Anti-decubitus air pump & air mattress system,Airwave 2010 serial Anti-decubitus air turning system,Airwave serial Anti-decubitus air pump & air mattress system,Easy care serial Anti-decubitus air pump & air mattress system,Sequoia 68D serial Anti-decubitus air pump & air mattress system,Sequoia 9700N… |
|---|---|
| Owner/operator | Sequoia-TWN Healthcare co. Ltd. |
| Owner/operator number | 10091186 |
| Product codes | FNM |
| Device names | FNM - Mattress, Air Flotation, Alternating Pressure |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5550 |
| Review panels | General Hospital |
| Registered establishments | SEQUOIA-TWN HEALTHCARE CO. LTD. |
| Establishment registrations | 3031754322 |
| FEI numbers | 3031754322 |
| 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