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510(k) Data Aggregation
K Number
K212618Device Name
iRelieve Microcurrent Pain Relief System
Manufacturer
Fast Track Technologies, Inc.
Date Cleared
2022-09-14
(392 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Fast Track Technologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The iRelieve Microcurrent Pain Relief System is intended to be used by physicians or licensed practitioners for symptomatic relief of chronic intractable pain.
Device Description
The iRelieve Microcurrent Pain Relief System is a microcurrent TENS device that operates by sending electrical impulses through the skin to the nerves lying directly beneath the skin surface. These impulses help block the body's ability to send a pain message to the brain, thereby reducing the pain sensation. The iRelieve Microcurrent Pain Relief System is a single channel device that produces microampere currents with the selected envelopes, waveforms, frequencies, and polarity, with a maximum voltage of 3.0 volts. It is controlled by analogue electrical parts (voltage regulator, frequency oscillator, multiple resistors, etc.) and a digital microprocessor chip that contains embedded programmed software (firmware) that generates a sequence of current flows and frequencies during the course of a single treatment session. The iRelieve Microcurrent Pain Relief System performs this sequence of current flows without user manipulation or device controls other than switching the device on after application of the device to the electrodes.
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