Non-Invasive Vagus Nerve Stimulator - Headache

PKR · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5892

Classification

FDA Product Code: PKR
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.5892
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat cluster headache and to reduce the frequency of cluster headache attacks.

Market data

Cleared 510(k) submissions: 9
Registered establishments: 1

Source

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