PLU · Class II · 21 CFR 882.5700

FDA Product Code PLU: Thermal System For Insomnia

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.

Leading manufacturers include Cereve, Inc..

Total

Cleared

571d

Avg days

2016

Since

FDA 510(k) Cleared Thermal System For Insomnia Devices (Product Code PLU)

1 devices

1–1 of 1

Not Cleared May 13, 2016

About Product Code PLU - Regulatory Context

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Data Source

FDA 510(k) public files . 175,972 total devices indexed.

Latest clearance: May 13, 2016

Product Code Info

Code	PLU
Device class	Class II
CFR	21 CFR 882.5700
Panel	Neurology

Verify on FDA.gov

View PLU classification on FDA.gov →