Cleared Traditional

K901797 - THE WONDER BOX

K901797 is the FDA 510(k) clearance for THE WONDER BOX by Micro Tronics Corp.. It is a Class 2 Neurology device (product code GWL) cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K901797 · Micro Tronics Corp. · Neurology device
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Feb 1991
Decision
294d
Days
Class 2
Risk

K901797 is an FDA 510(k) clearance for the THE WONDER BOX. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Micro Tronics Corp. (Carrboro, US). The FDA issued a Cleared decision on February 7, 1991 after a review of 294 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1835 - 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 Micro Tronics Corp. devices

Submission Details

510(k) Number K901797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1990
Decision Date February 07, 1991
Days to Decision 294 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 148d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWL Amplifier, Physiological Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1835
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 - GWL Amplifier, Physiological Signal

All 17
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K901797.
Digital NeuroPort Biopotential Signal Processing System
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K881177 · Nihon Kohden America, Inc. · Sep 1988
MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER
K870794 · Nihon Kohden America, Inc. · Sep 1987
NEUROPACK II 5100
K841612 · Nihon Kohden America, Inc. · Jun 1984