NHI

13 FDA 510(k) clearances · Product code

FDA profile

Official device name

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

Device class

Class II (moderate risk)

Regulation

21 CFR 882.5890

Medical specialty

Neurology

Flags

Third-party review eligible

FDA 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,

Adverse events (MAUDE)

2023: 25
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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