Cleared Traditional

K884071 - AMPLAID EMG15

K884071 is an FDA 510(k) clearance for AMPLAID EMG15, manufactured by Amplus Corp.. The device is a Class 2 Neurology device with product code GWL cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K884071 · Amplus Corp. · Neurology device
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Feb 1989
Decision
153d
Days
Class 2
Risk

K884071 is an FDA 510(k) clearance for the AMPLAID EMG15. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Amplus Corp. (Boulder, US). The FDA issued a Cleared decision on February 27, 1989 after a review of 153 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.

FDA 510(k) Submission Details - K884071

510(k) Number K884071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1988
Decision Date February 27, 1989
Days to Decision 153 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 149d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWL Device Classification - Class 2, Special Controls

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 40
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K884071.
SENSOR AMPLIFIER
K972515 · Pro-Tech Services, Inc. · Oct 1997
GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM
K963669 · Astro-Med, Inc. · Dec 1996
MMC AMPLIFIER
K943673 · Melville Software , Ltd. · Oct 1994
MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD
K881177 · Nihon Kohden America, Inc. · Sep 1988
MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER
K870794 · Nihon Kohden America, Inc. · Sep 1987
NICOLET AMP 6R11 SYSTEM
K871678 · Nicolet Biomedical Instruments · Jul 1987
K884071 · AMPLAID EMG15
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