Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

QGH · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5940

Classification

FDA Product Code: QGH
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.5940
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.

Market data

Cleared 510(k) submissions: 9
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown