iRelieve Microcurrent Pain Relief System

FDA 510(k) K212618 · Fast Track Technologies, Inc.

Substantially Equivalent

510(k) numberK212618

Submission

Device name
iRelieve Microcurrent Pain Relief System
Applicant
Fast Track Technologies, Inc.
Newport Beach, CA, US
Received
August 18, 2021
Decision date
September 14, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

Other 510(k)s with product code GZJ

510(k)DeviceApplicantDecision
K252712STIMPOD NMS460 Nerve StimulatorGZJ · Traditional Algiamed Technologies USA, Inc.05/28/2026SE
K252767actiTENS miniGZJ · Traditional Sublimed01/16/2026SE
K252236CP Relief Wand Rx - TENS/NMESGZJ · Special N & C Holdings, LLC08/15/2025SE
K232441Unipro (K-UNIPRO-US)GZJ · Traditional Tenscare, Ltd.08/30/2024SE
K241228TENSWaveGZJ · Abbreviated Zynex Medical Officer08/27/2024SE
K233046Electrical Neuromuscular Stimulator, Cure TrioGZJ · Traditional Oriental Inspiration Limited04/19/2024SE
K222879Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)GZJ · Traditional Wuxi Jiajian Medical Instrument Co., Ltd.01/24/2023SE
K213802StimOnTM Pain Relief System (GM2439)GZJ · Traditional Gimer Medical Co., Ltd.08/26/2022SE
K220578Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)GZJ · Traditional Bozhou Rongjian Medical Appliance Co., Ltd.05/25/2022SE
K220503TENS device-EmeTerm 2, Model: YF-ZTY-E2GZJ · Traditional Wat Medical Technology, Inc.04/23/2022SE

Questions and answers

When was iRelieve Microcurrent Pain Relief System cleared by the FDA?

iRelieve Microcurrent Pain Relief System (K212618) received a 510(k) decision of Substantially Equivalent on September 14, 2022, 392 days after the submission was received.

What is the product code of K212618?

The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.