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FDA 510(k)

FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W

K-Number: K161282 · 2016-10-30

ApplicantMedico Electrodes International , Ltd.
Decision Date2016-10-30
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W is a medical device manufactured by Medico Electrodes International , Ltd.. It received FDA 510(k) clearance on 2016-10-30 under approval number K161282. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W?

FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W is a medical device that received FDA 510(k) clearance on 2016-10-30. It is manufactured by Medico Electrodes International , Ltd.. The 510(k) number is K161282.

When was FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W approved by the FDA?

FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W received FDA 510(k) clearance on 2016-10-30, under approval number K161282.

What company makes FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W?

FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W is manufactured by Medico Electrodes International , Ltd..

What is the FDA product code for FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W?

The FDA product code for FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W is GXY.

Related Clinical Trials

NCT07588490 Treatment of Acute Low Back Pain With Transcutaneous Electrical Neurostimulation in Emergency Departments RECRUITING NCT02875964 Definition of Links Between Non-invasives Methods and Intracerebral EEG With Simultaneous Recordings. COMPLETED NCT06235970 Cognitive Enhancement Through Model-based and Individualized Neurostimulation COMPLETED NCT05343988 Percutaneous Neurostimulation to Treat Paroxysmal Sympathetic Hyperactivity in Children TERMINATED NCT04675398 Adaptive Deep Brain Stimulation to Improve Motor and Gait Functions in Parkinson's Disease ACTIVE_NOT_RECRUITING NCT06155695 Auditory Control Enhancement (ACE) in Schizophrenia TERMINATED

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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