FDA product code PLU: Thermal System For Insomnia
PLU is the FDA product code for thermal system for insomnia. It is a Class II device, regulated under 21 CFR 882.5700 and reviewed by the Neurology panel. Devices under PLU reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Thermal System For Insomnia |
| Device class | Class II |
| Regulation | 21 CFR 882.5700 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for PLU devices
openFDA lists no recalls for product code PLU.
Frequently asked questions
What is FDA product code PLU?
PLU is the FDA product code for thermal system for insomnia. It is a Class II device, regulated under 21 CFR 882.5700 and reviewed by the Neurology panel.
What device class is PLU?
Class II, regulation 21 CFR 882.5700. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PLU
- Run a recall and safety report across every PLU manufacturer
- Watch product code PLU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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