QJQ

Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

Product code
QJQ
Device name
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Device class
Class 2
21 CFR
21 CFR 882.5800
Medical specialty
Neurology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
3
Summaries archived here
3 (direct download)
510(k) clearances (all years, FDA)
19 (all years; only the last 3 years are listed here)

FDA classification definition

To provide electrical current to the head to treat insomnia and/or anxiety

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

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-12-31.

NumberDecision dateApplicantDevice nameSummary
K2529512025-12-31Neurofield, Inc.Genesis SleepPDF
K2322532024-03-27Neurovalens LimitedModius StressPDF
K2308262023-10-27Neurovalens , Ltd.Modius SleepPDF

3 summaries are archived here for direct download.

Official FDA classification page: QJQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).