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FDA 510(k)

HORIZON Therapy System

K-Number: K171051 · 2017-09-13

ApplicantMagstim Company, Ltd.
Decision Date2017-09-13
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HORIZON Therapy System is a medical device manufactured by Magstim Company, Ltd.. It received FDA 510(k) clearance on 2017-09-13 under approval number K171051. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HORIZON Therapy System?

HORIZON Therapy System is a medical device that received FDA 510(k) clearance on 2017-09-13. It is manufactured by Magstim Company, Ltd.. The 510(k) number is K171051.

When was HORIZON Therapy System approved by the FDA?

HORIZON Therapy System received FDA 510(k) clearance on 2017-09-13, under approval number K171051.

What company makes HORIZON Therapy System?

HORIZON Therapy System is manufactured by Magstim Company, Ltd..

What is the FDA product code for HORIZON Therapy System?

The FDA product code for HORIZON Therapy System is OBP.

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 29653650 Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data. American heart journal (2018)

Other Devices by Magstim Company, Ltd.

K162935Rapid2 Therapy System K181559Neurosign V4 Intraoperative Nerve Monitor K180907HORIZON TMS Therapy System K183376HORIZON TMS Therapy System with Navigation K182853HORIZON TMS Therapy System K211389Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation

View all 10 devices →

Related Devices (Code: OBP)

K160309Neurosoft TMSTeleemg, LLC K161519NeuroStar TMS Therapy SystemNeuronetics, Inc. K160703NeuroStar TMS Therapy SystemNeuronetics, Inc. K173441Neurosoft TMS (also CloudTMS)Teleemg, LLC K171902Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc K172667MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S

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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