NHI · Class II · 21 CFR 882.5890

FDA Product Code NHI: Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief

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,

Leading manufacturers include Spr Therapeutics, Inc., Dyansys, Inc. and Spr Therapeutics, LLC.

13
Total
13
Cleared
107d
Avg days
2001
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief Devices (Product Code NHI)

13 devices
1–13 of 13
Cleared Jan 25, 2023
SPRINT Peripheral Nerve Stimulation (PNS) System
K223306
Spr Therapeutics, Inc.
Neurology · 90d
Cleared Sep 13, 2022
Primary Relief
K221425
Dyansys, Inc.
Neurology · 120d
Cleared May 12, 2022
ANSiStim-PP
K220397
Dyansys, Inc.
Neurology · 90d
Cleared Jan 31, 2022
Primary Relief
K213188
Dyansys, Inc.
Neurology · 124d
Cleared Dec 20, 2021
First Relief
K212859
Dyansys, Inc.
Neurology · 103d
Cleared Oct 13, 2021
SPRINT PNS System
K211801
Spr Therapeutics, Inc.
Neurology · 125d
Cleared Jan 22, 2021
SPRINT PNS System
K202660
Spr Therapeutics, Inc.
Neurology · 130d
Cleared Jul 31, 2018
SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit
K181422
Spr Therapeutics, Inc.
Neurology · 61d
Cleared Jun 26, 2017
Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit
K170902
Spr Therapeutics, LLC
Neurology · 90d
Cleared Jul 23, 2016
Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs
K161154
Spr Therapeutics, LLC
Neurology · 89d
Cleared Aug 15, 2006
DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM
K061166
Biowave Corporation
Neurology · 110d
Cleared Dec 21, 2001
VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX
K011702
Vertis Neuroscience, Inc.
Neurology · 203d

About Product Code NHI - Regulatory Context

510(k) Submission Activity

13 total 510(k) submissions under product code NHI since 2001, with 13 receiving FDA clearance (average review time: 107 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.