NHI

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

Product code

NHI

Device name

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

Device class

Class 2

21 CFR

21 CFR 882.5890

Medical specialty

Neurology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

13 (all years; only the last 3 years are listed here)

FDA classification 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,

Definition text from the FDA device classification database (U.S. federal government work, public domain).