Cleared Traditional

K901732 - EMG ACCESSORY FOR POSTUROGRAPHY

K901732 is the FDA 510(k) clearance for EMG ACCESSORY FOR POSTUROGRAPHY by Neurocom International, Inc.. It is a Class 2 Neurology device (product code IKN) cleared through the Traditional 510(k) pathway after a 511-day FDA review.

K901732 · Neurocom International, Inc. · Neurology device
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Sep 1991
Decision
511d
Days
Class 2
Risk

K901732 is an FDA 510(k) clearance for the EMG ACCESSORY FOR POSTUROGRAPHY. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Neurocom International, Inc. (Clackamas, US). The FDA issued a Cleared decision on September 10, 1991 after a review of 511 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Neurocom International, Inc. devices

Submission Details

510(k) Number K901732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1990
Decision Date September 10, 1991
Days to Decision 511 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
363d slower than avg
Panel avg: 148d · This submission: 511d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 - IKN Electromyograph, Diagnostic

All 13
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K901732.
EXCEL EMG
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NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT
K930328 · Bio-Logic Systems Corp. · Jul 1993
PHASIS ELECTROMYOGRAPH
K922488 · Biosound, Inc. · Mar 1993
EMG NAVIGATOR & EMG TRAVELER
K893130 · Bio-Logic Systems Corp. · Mar 1990
KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
K864630 · Chattanooga Group, Inc. · Dec 1986
EMG MODULES FOR POLYGRAPH SYSTEM
K823562 · Nihon Kohden America, Inc. · Jan 1983