Cleared Traditional

K213900 - WAVi SCAN EEG System and Accessories

K213900 is an FDA 510(k) clearance for WAVi SCAN EEG System and Accessories, manufactured by Wavi Co.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K213900 · Wavi Co. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
143d
Days
Class 2
Risk

K213900 is an FDA 510(k) clearance for the WAVi SCAN EEG System and Accessories. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Wavi Co. (Denver, US). The FDA issued a Cleared decision on May 6, 2022 after a review of 143 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 Wavi Co. devices

FDA 510(k) Submission Details - K213900

510(k) Number K213900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2021
Decision Date May 06, 2022
Days to Decision 143 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 148d · This submission: 143d
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 101
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K213900.
Neuronaute with IceCap 2 & IceCap 2 Small
K223644 · Bioserenity · Jan 2023
iSyncWave
K220056 · iMediSync, Inc. · Aug 2022
Seer Home
K212788 · Seer Medical Pty, Ltd. · Jun 2022
NeuroAmp II, NeuroAmp II.5s
K193159 · Corscience GmbH & Co. KG · Dec 2020
Neuronaute
K202334 · Bioserenity Sas · Dec 2020
Cadwell Apollo System
K201819 · Cadwell Industries, Inc. · Sep 2020