FDA device listing
WellPatch HEAT THERAPY PAIN RELIEF PATCH,WellPatch MIGRAINE & HEADACHE Cooling Patch
FDA device listing 1652120633 · The Mentholatum Company
Key facts
| Proprietary names | WellPatch HEAT THERAPY PAIN RELIEF PATCH,WellPatch MIGRAINE & HEADACHE Cooling Patch |
|---|---|
| Owner/operator | The Mentholatum Company |
| Owner/operator number | 1310248 |
| 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 | MENTHOLATUM (CHINA) PHARMACEUTICALS CO., LTD., THE MENTHOLATUM COMPANY |
| Establishment registrations | 1320681, 9615433 |
| FEI numbers | 3000188423, 3000717606 |
| Establishment operations | Complaint File Establishment, Repackager/Relabeler, Specification Developer, 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