Cleared Traditional

iRelieve Microcurrent Pain Relief System

K212618 · Fast Track Technologies, Inc. · Neurology

Sep 2022

Decision

392d

Days

Class 2

Risk

About This 510(k) Submission

K212618 is an FDA 510(k) clearance for the iRelieve Microcurrent Pain Relief System, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Fast Track Technologies, Inc. (Newport Beach, US). The FDA issued a Cleared decision on September 14, 2022, 392 days after receiving the submission on August 18, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K212618 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 18, 2021
Decision Date	September 14, 2022
Days to Decision	392 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF