FDA product code PKR

Non-Invasive Vagus Nerve Stimulator - Headache

Neurology·Class 2·21 CFR 882.5892
US regulatory classifications
US Product Code (FDA)
PKR
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.5892
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Non-Invasive Vagus Nerve Stimulator - Headache is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.