FDA 510(k)

iRelieve Microcurrent Pain Relief System

Номер K: K212618 · 2022-09-14

Дата решения2022-09-14

Код продуктаGZJ

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: GZJ)

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimed K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical Officer K233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

Официальный источник

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