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NHIClass II

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

21 CFR 882.5890 / Neurology

NHI is the FDA product code for Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief, a class II device type, regulated under 21 CFR 882.5890. FDA's definition for this code reads: "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...". As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NHI
Device name
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
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,
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
13
Ingested recalls
0

Clearances, product code NHI

By decision year
13 clearances under product code NHI with a decision year between 2001 and 2023, 2021 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code NHI by decision year
YearClearances
20011
20021
20061
20161
20171
20181
20213
20223
20231

Applicants with the most clearances

Product code NHI
Applicants holding the most 510(k) clearances under product code NHI
ApplicantClearances
SPR Therapeutics, Inc6
Dyansys, Inc.4
Vertis Neuroscience, Inc.2
Biowave Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code