IRelieve Microcurrent Pain Relief System

Stimulator, Nerve, Transcutaneous, For Pain Relief

Fast Track Technologies, Inc.

The following data is part of a premarket notification filed by Fast Track Technologies, Inc. with the FDA for Irelieve Microcurrent Pain Relief System.

Pre-market Notification Details

Device IDK212618
510k NumberK212618
Device Name:IRelieve Microcurrent Pain Relief System
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant Fast Track Technologies, Inc. 4400 MacArther Blvd., Ste. 900 Newport Beach,  CA  92660
ContactGeoffrey Pfeifer
CorrespondentStephen Goldner
Regulatory Affairs Associates, LLC. 4761 Tara Court West Bloomfield,  MI  48323
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-18
Decision Date2022-09-14

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