DeviceClearance

Product code NHI— Neurology

Primary Relief

Classification name
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
Device class
Class 2
Regulation
21 CFR 882.5890
Advisory panel
Neurology
Total cleared
13
First cleared
Most recent

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,”

— U.S. Food and Drug Administration, device classification record for product code NHI under 21 CFR 882.5890, via openFDA

Market context for product code NHI

FDA has cleared 13 devices under product code NHI between 2001 and 2023, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NHI

Recent clearances under product code NHI

Data sourced from openFDA. This site is unofficial and independent of the FDA.