Cleared Traditional

K941144 - EXCEL EMG

K941144 is an FDA 510(k) clearance for EXCEL EMG, manufactured by Excel Tech. , Ltd.. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 607-day FDA review.

K941144 · Excel Tech. , Ltd. · Neurology device
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Nov 1995
Decision
607d
Days
Class 2
Risk

K941144 is an FDA 510(k) clearance for the EXCEL EMG. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Excel Tech. , Ltd. (Oakville,Ontario, CA). The FDA issued a Cleared decision on November 7, 1995 after a review of 607 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.

FDA 510(k) Submission Details - K941144

510(k) Number K941144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1994
Decision Date November 07, 1995
Days to Decision 607 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
458d slower than avg
Panel avg: 149d · This submission: 607d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKN Device Classification - Class 2, Special Controls

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 74
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K941144.
MLS ELECTROMYOGRAPHIC PREAMPLIFIER
K974385 · Motion Lab Systems, Inc. · Feb 1998
ADVANTAGE EMG SYSTEM, MODEL #A100
K974010 · Advantage Medical Division of Cme Telemetrix · Jan 1998
ADVANTAGE 3000
K973355 · Advantage Medical Division of Cme Telemetrix · Dec 1997
COMPUTER DYNO/GONIO/MYO GRAPHY
K942965 · Infotronic Medical Engineering · Oct 1995
B & L ELECTRODE
K952655 · B & L Engineering · Sep 1995
INTEGRATED MOVEMENT ANALYZER
K944787 · Maryrose · Jul 1995
K941144 · EXCEL EMG
Download PDF Excel Tech. , Ltd.