Cleared Traditional

K171124 - Nihon Kohden Wireless Input Unit WEE-1200

K171124 is an FDA 510(k) clearance for Nihon Kohden Wireless Input Unit WEE-1200, manufactured by Nihon Kohden Corporation. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K171124 · Nihon Kohden Corporation · Neurology device
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Aug 2017
Decision
130d
Days
Class 2
Risk

K171124 is an FDA 510(k) clearance for the Nihon Kohden Wireless Input Unit WEE-1200. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Nihon Kohden Corporation (Tokyo, JP). The FDA issued a Cleared decision on August 25, 2017 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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 Nihon Kohden Corporation devices

FDA 510(k) Submission Details - K171124

510(k) Number K171124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2017
Decision Date August 25, 2017
Days to Decision 130 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
18d faster than avg
Panel avg: 148d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWQ Device Classification - Class 2, Special Controls

Product Code GWQ Full-montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations
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 - GWQ Full-montage Standard Electroencephalograph

All 97
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