Cleared Traditional

K113785 - ADHERENT VISUAL STIMULATOR GOGGLES

K113785 is an FDA 510(k) clearance for ADHERENT VISUAL STIMULATOR GOGGLES, manufactured by Anschel Technology, Inc.. The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K113785 · Anschel Technology, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
166d
Days
Class 2
Risk

K113785 is an FDA 510(k) clearance for the ADHERENT VISUAL STIMULATOR GOGGLES. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Anschel Technology, Inc. (New York, US). The FDA issued a Cleared decision on June 6, 2012 after a review of 166 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1890 - 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.

FDA 510(k) Submission Details - K113785

510(k) Number K113785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2011
Decision Date June 06, 2012
Days to Decision 166 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
17d slower than avg
Panel avg: 149d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWE Device Classification - Class 2, Special Controls

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
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 - GWE Stimulator, Photic, Evoked Response

All 43
Devices cleared under the same product code (GWE) and FDA review panel - the closest regulatory comparables to K113785.
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LIFELINES PHOTIC STIMULATOR
K101691 · Lifelines , Ltd. · Aug 2010
K113785 · ADHERENT VISUAL STIMULATOR GOGGLES
Download PDF FDA Summary Anschel Technology, I…