PLU

Thermal System For Insomnia

Product code: PLU
Device name: Thermal System For Insomnia
Device class: Class 2
21 CFR: 21 CFR 882.5700
Medical specialty: Neurology
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PLU

Classification and pathway per current FDA publications. Data from openFDA (CC0).