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FDA 510(k)

StimQ Peripheral Nerve Stimulator (PNS) System

K-Number: K152178 · 2016-03-11

ApplicantStimq, LLC
Decision Date2016-03-11
Product CodeGZF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

StimQ Peripheral Nerve Stimulator (PNS) System is a medical device manufactured by Stimq, LLC. It received FDA 510(k) clearance on 2016-03-11 under approval number K152178. The device is classified under product code GZF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StimQ Peripheral Nerve Stimulator (PNS) System?

StimQ Peripheral Nerve Stimulator (PNS) System is a medical device that received FDA 510(k) clearance on 2016-03-11. It is manufactured by Stimq, LLC. The 510(k) number is K152178.

When was StimQ Peripheral Nerve Stimulator (PNS) System approved by the FDA?

StimQ Peripheral Nerve Stimulator (PNS) System received FDA 510(k) clearance on 2016-03-11, under approval number K152178.

What company makes StimQ Peripheral Nerve Stimulator (PNS) System?

StimQ Peripheral Nerve Stimulator (PNS) System is manufactured by Stimq, LLC.

What is the FDA product code for StimQ Peripheral Nerve Stimulator (PNS) System?

The FDA product code for StimQ Peripheral Nerve Stimulator (PNS) System is GZF.

Related Clinical Trials

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Related PubMed Literature

PMID: 41470022 Low-intensity pulsed ultrasound for peripheral nerve regeneration: mechanobiological mechanisms and translational potential. Journal of translational medicine (2025) PMID: 40077817 Research Progress on Neural Cell Culture Systems. Current neuropharmacology (2025)

Related Devices (Code: GZF)

K171366Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger KitStimwave Technologies Inc., Dba Stimq, LLC K190047StimRouter Neuromodulation SystemBioness, Inc. K191435IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4Nalu Medical, Inc. K183579Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kitsBoston Scientific Neuromodulation K200848Stimulator, Stimulator Kit, External Transmitter, External Transmitter KitMicron Medical Corporation K200482StimRouter Neuromodulation SystemBioness, Inc.

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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