FDA device listing
Burncare Cooling Pads,Capsicum Plaster,Cold & Hot Medicated Patch,Cool N Heat Patch,Cool Patch,FLANAX PATCH,Heat Patch…
FDA device listing 1245707678 · Foshan Aqua Gel Biotech Co. Ltd.
Key facts
| Proprietary names | Burncare Cooling Pads,Capsicum Plaster,Cold & Hot Medicated Patch,Cool N Heat Patch,Cool Patch,FLANAX PATCH,Heat Patch Air Activated,Hot Patch,Instant Cold or Hot Pack,Medicated Cooling Fever Patch,Menthol Small Patch,Migraine Hydrogel Patch,Skin Plaster,Ultra Stregth Pain Relieving Patch,Warm Pad |
|---|---|
| Owner/operator | Foshan Aqua Gel Biotech Co. Ltd. |
| Owner/operator number | 10026638 |
| Product codes | IMD |
| Device names | IMD - Pack, Hot Or Cold, Disposable |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5710 |
| Review panels | Physical Medicine |
| Registered establishments | FOSHAN AQUA GEL BIOTECH CO. LTD. |
| Establishment registrations | 3007222546 |
| FEI numbers | 3007222546 |
| 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