Cleared Traditional

Primary Relief

K221425 · Dyansys, Inc. · Neurology
Sep 2022
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K221425 is an FDA 510(k) clearance for the Primary Relief, a Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief (Class II — Special Controls, product code NHI), submitted by Dyansys, Inc. (San Mateo, US). The FDA issued a Cleared decision on September 13, 2022, 120 days after receiving the submission on May 16, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K221425 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2022
Decision Date September 13, 2022
Days to Decision 120 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code NHI — Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890
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,