510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PLUClass II

Thermal System For Insomnia

21 CFR 882.5700 / Neurology
FDA source (opens on fda.gov)

PLU is the FDA product code for Thermal System For Insomnia, a class II device type, regulated under 21 CFR 882.5700. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PLU
Device name
Thermal System For Insomnia
FDA 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.
Regulation
21 CFR 882.5700
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PLU

By decision year
1 clearance under product code PLU with a decision year between 2016 and 2016, 2016 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PLU by decision year
YearClearances
20161

Applicants with the most clearances

Product code PLU
Applicants holding the most 510(k) clearances under product code PLU
ApplicantClearances
Cereve, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code PLU.