Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Freedom Peripheral Nerve Stimulator (PNS) System

K-Number: K233162 · 2024-06-20

ApplicantCuronix
Decision Date2024-06-20
Product CodeGZF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Freedom Peripheral Nerve Stimulator (PNS) System is a medical device manufactured by Curonix. It received FDA 510(k) clearance on 2024-06-20 under approval number K233162. 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 Freedom Peripheral Nerve Stimulator (PNS) System?

Freedom Peripheral Nerve Stimulator (PNS) System is a medical device that received FDA 510(k) clearance on 2024-06-20. It is manufactured by Curonix. The 510(k) number is K233162.

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

Freedom Peripheral Nerve Stimulator (PNS) System received FDA 510(k) clearance on 2024-06-20, under approval number K233162.

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

Freedom Peripheral Nerve Stimulator (PNS) System is manufactured by Curonix.

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

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

Related Clinical Trials

NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07613489 Photobiomodulation for Diabetic Peripheral Neuropathy ACTIVE_NOT_RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING

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)

K152178StimQ Peripheral Nerve Stimulator (PNS) SystemStimq, LLC 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

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.

↑