Cleared Traditional

K161282 - FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161282 · Medico Electrodes International , Ltd. · Neurology device
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Oct 2016
Decision
177d
Days
Class 2
Risk

K161282 is an FDA 510(k) clearance for the FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 505.... Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Medico Electrodes International , Ltd. (Noida, IN). The FDA issued a Cleared decision on October 30, 2016 after a review of 177 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medico Electrodes International , Ltd. devices

Submission Details

510(k) Number K161282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2016
Decision Date October 30, 2016
Days to Decision 177 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 148d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXY Electrode, Cutaneous

All 433
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