Product Code: NHI FDA class 2 21 CFR 882.5890

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

Neurology

The Stimulator, Nerve, Electrical, Percutaneous (PENS), For Pain (product code NHI) is a neurology device that delivers electrical stimulation via percutaneously placed needle electrodes adjacent to peripheral nerves or nerve plexuses to treat chronic or acute pain, as described in its definition. It is classified as an FDA Class 2 device within the Neurology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as a permanent implant or life-sustaining device.

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FEI Numbers

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Basic Information

Product Code: NHI
Device Class: FDA class 2
Regulation Number: 882.5890
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

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,

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 13 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K223306	SPRINT Peripheral Nerve Stimulation (PNS) System	Jan 25, 2023	Substantially Equivalent	Spr Therapeutics, Inc.
K221425	Primary Relief	Sep 13, 2022	Substantially Equivalent	Dyansys, Inc.
K220397	ANSiStim-PP	May 12, 2022	Substantially Equivalent	Dyansys, Inc.
K213188	Primary Relief	Jan 31, 2022	Substantially Equivalent	Dyansys, Inc.
K212859	First Relief	Dec 20, 2021	Substantially Equivalent	Dyansys, Inc.
K211801	SPRINT PNS System	Oct 13, 2021	Substantially Equivalent	Spr Therapeutics, Inc.
K202660	SPRINT PNS System	Jan 22, 2021	Substantially Equivalent	Spr Therapeutics, Inc.
K181422	SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit	Jul 31, 2018	Substantially Equivalent	Spr Therapeutics, Inc.
K170902	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	Jun 26, 2017	Substantially Equivalent	Spr Therapeutics, LLC
K161154	Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs	Jul 23, 2016	Substantially Equivalent	Spr Therapeutics, LLC
K061166	DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM	Aug 15, 2006	Substantially Equivalent	Biowave Corporation
K022241	VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX	Sep 11, 2002	Substantially Equivalent	Vertis Neuroscience, Inc.
K011702	VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX	Dec 21, 2001	Substantially Equivalent	Vertis Neuroscience, Inc.