FDA device listing
Gel overylay
FDA device listing 1960426881 · Sichuan AST Medical Equipment Co., Ltd
Key facts
| Proprietary names | Gel overylay |
|---|---|
| Owner/operator | Sichuan AST Medical Equipment Co., Ltd |
| Owner/operator number | 10030716 |
| Product codes | FOH |
| Device names | FOH - Mattress, Water, Temperature Regulated |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.5560 |
| Review panels | General Hospital |
| Registered establishments | Sichuan AST Medical Equipment Co., Ltd |
| Establishment registrations | 3008058406 |
| FEI numbers | 3008058406 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, 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