Cleared Traditional

First Relief

K212859 · Dyansys, Inc. · Neurology
Dec 2021
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K212859 is an FDA 510(k) clearance for the First 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 December 20, 2021, 103 days after receiving the submission on September 8, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K212859 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2021
Decision Date December 20, 2021
Days to Decision 103 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,