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FDA PMA

Cranial electrotherapy stimulator to treat depression

PMA Number: P250010 · 2025-12-31

ApplicantNeurolief , Ltd.
Decision Date2025-12-31
PMA NumberP250010
Product CodeJXK
Device ClassClass 3
Medical SpecialtyN
Regulation Number21 CFR 8
Advisory CommitteeNE

Device Summary

Cranial electrotherapy stimulator to treat depression is the device name listed in this FDA 510(k) record. The listed applicant is Neurolief , Ltd.. It received FDA 510(k) clearance on 2025-12-31. The device is classified under product code JXK. It was reviewed by the NE advisory panel.

Frequently Asked Questions

What is the Cranial electrotherapy stimulator to treat depression?

Cranial electrotherapy stimulator to treat depression is a medical device that received FDA 510(k) clearance on 2025-12-31. The listed applicant is Neurolief , Ltd..

When did Cranial electrotherapy stimulator to treat depression receive FDA 510(k) clearance?

The clearance date for Cranial electrotherapy stimulator to treat depression can be found in the official FDA records.

Who is the listed applicant for Cranial electrotherapy stimulator to treat depression?

The FDA 510(k) record lists Neurolief , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cranial electrotherapy stimulator to treat depression?

The FDA product code for Cranial electrotherapy stimulator to treat depression is JXK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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