Product code
PLU: Thermal system for insomnia
FDA product code · Class II · Neurology
Key facts
| Product code | PLU |
|---|---|
| Device | Thermal system for insomnia |
| Device class | Class II |
| Regulation number | 882.5700 |
| Review panel | Neurology |
| Medical specialty | Neurology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A thermal system for insomnia is a prescription device for use in patients with insomnia that is used to apply a specified temperature to the skin surface. |
At a glance
- None 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database