510(k) K221425

Primary Relief by Dyansys, Inc. — Product Code NHI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 13, 2022
Date Received: May 16, 2022
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
Device Class: Class II
Regulation Number: 882.5890
Review Panel: NE
Submission Type

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,

Other clearances by Dyansys, Inc.

K221231 — Drug Relief v1 (June 6, 2022)
K220397 — ANSiStim-PP (May 12, 2022)
K213188 — Primary Relief (January 31, 2022)
K212859 — First Relief (December 20, 2021)
K211971 — Drug Relief v1 (November 5, 2021)
K202940 — First Relief v1 (December 29, 2020)
K173861 — Drug Relief (May 2, 2018)
K170391 — ANSiStim-PP (March 9, 2017)
K141168 — ANSISTIM (May 15, 2015)
K091397 — ECSCOPE 200 (July 8, 2009)

Other clearances for product code NHI

K223306 — SPRINT Peripheral Nerve Stimulation (PNS) System (January 25, 2023)
K220397 — ANSiStim-PP (May 12, 2022)
K213188 — Primary Relief (January 31, 2022)
K212859 — First Relief (December 20, 2021)
K211801 — SPRINT PNS System (October 13, 2021)
K202660 — SPRINT PNS System (January 22, 2021)
K181422 — SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Sti (July 31, 2018)
K170902 — Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure (June 26, 2017)
K161154 — Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and A (July 23, 2016)
K061166 — DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM (August 15, 2006)