FDA 510(k)

iRelieve Microcurrent Pain Relief System

Numéro K : K212618 · 2022-09-14

Date de décision2022-09-14

Code produitGZJ

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : GZJ)

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Source officielle

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