FDA 510(k)

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit

Номер K: K171366 · 2017-08-04

ЗаявительStimwave Technologies Inc., Dba Stimq, LLC

Дата решения2017-08-04

Код продуктаGZF

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit is the device name listed in this FDA 510(k) record. The listed applicant is Stimwave Technologies Inc., Dba Stimq, LLC. It received FDA 510(k) clearance on 2017-08-04 under 510(k) number K171366. The device is classified under product code GZF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit?

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit is a medical device that received FDA 510(k) clearance on 2017-08-04. The listed applicant is Stimwave Technologies Inc., Dba Stimq, LLC. The 510(k) number is K171366.

When did Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit receive FDA 510(k) clearance?

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit received FDA 510(k) clearance on 2017-08-04, under 510(k) number K171366.

Who is the listed applicant for Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit?

The FDA 510(k) record lists Stimwave Technologies Inc., Dba Stimq, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit?

The FDA product code for Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit is GZF.

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: GZF)

K253877StimTrial Neuromodulation SystemBioventus, LLC K243782StimTrial Neuromodulation SystemBioventus, LLC K243678TalisMann Neuromodulation SystemBioventus, LLC K232415Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation K233162Freedom Peripheral Nerve Stimulator (PNS) SystemCuronix K221303Neuspera Nuity SystemNeuspera Medical, Inc.

Официальный источник

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