Cleared Traditional

Primary Relief

K213188 · Dyansys, Inc. · Neurology
Jan 2022
Decision
124d
Days
Class 2
Risk

About This 510(k) Submission

K213188 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 January 31, 2022, 124 days after receiving the submission on September 29, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K213188 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2021
Decision Date January 31, 2022
Days to Decision 124 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,