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FDA 510(k)

iRelieve Microcurrent Pain Relief System

K-Number: K212618 · 2022-09-14

ApplicantFast Track Technologies, Inc.
Decision Date2022-09-14
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

iRelieve Microcurrent Pain Relief System is the device name listed in this FDA 510(k) record. The listed applicant is Fast Track Technologies, Inc.. It received FDA 510(k) clearance on 2022-09-14 under 510(k) number K212618. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iRelieve Microcurrent Pain Relief System?

iRelieve Microcurrent Pain Relief System is a medical device that received FDA 510(k) clearance on 2022-09-14. The listed applicant is Fast Track Technologies, Inc.. The 510(k) number is K212618.

When did iRelieve Microcurrent Pain Relief System receive FDA 510(k) clearance?

iRelieve Microcurrent Pain Relief System received FDA 510(k) clearance on 2022-09-14, under 510(k) number K212618.

Who is the listed applicant for iRelieve Microcurrent Pain Relief System?

The FDA 510(k) record lists Fast Track Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iRelieve Microcurrent Pain Relief System?

The FDA product code for iRelieve Microcurrent Pain Relief System is GZJ.

Related Devices (Code: GZJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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