FDA device listing
ICEFLOW Cold Therapy System
FDA device listing 1405702809 · Suzhou Minhua Medical Equipment Co.,Ltd.
Key facts
| Proprietary names | ICEFLOW Cold Therapy System |
|---|---|
| Owner/operator | Suzhou Minhua Medical Equipment Co.,Ltd. |
| Owner/operator number | 10048668 |
| Product codes | ILO |
| Device names | ILO - Pack, Hot Or Cold, Water Circulating |
| Device class | Class II |
| Classification regulations (21 CFR) | 890.5720 |
| Review panels | Physical Medicine |
| Registered establishments | Suzhou Minhua Medical Equipment Co.,Ltd. |
| Establishment registrations | 3011529836 |
| FEI numbers | 3011529836 |
| 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