FDA product code NHI

Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief

Neurology·Class 2·21 CFR 882.5890
US regulatory classifications
US Product Code (FDA)
NHI
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.5890
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
Definition

Percutaneous electrical nerve stimulator (pens) is a device used for the treatment of pain. Unlike the classified transcutaneous electrical nerve stimulator that apply an electrical current to electrodes on a patient's skin to deliver stimulation, a pens uses electrodes that are placed percutaneously to deliver stimulation,

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About this record

Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief 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.