Cleared Traditional

K890274 - MEM-7102

Also marketed or referenced as:
MEB-7102 EVOKED RESPONSE & ELECTRO RECOR

K890274 is an FDA 510(k) clearance for MEM-7102, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K890274 · Nihon Kohden America, Inc. · Neurology device
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May 1989
Decision
120d
Days
Class 2
Risk

K890274 is an FDA 510(k) clearance for the MEM-7102. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on May 18, 1989 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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 Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K890274

510(k) Number K890274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1989
Decision Date May 18, 1989
Days to Decision 120 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 148d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 60
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K890274.
DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2)
K902607 · Dantec Medical, Inc. · May 1991
SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME
K903731 · Teca, Inc. · Feb 1991
CANTATA EMG/EVOKED RESPONSE SYSTEM
K896567 · Dantec Medical, Inc. · Feb 1990
TECA/MEDELEC 'CONCEPT' P420
K884870 · Teca, Inc. · Feb 1989
CADWELL EXCEL
K880088 · Cadwell Laboratories, Inc. · May 1988
NOVAMETRIX MODEL 200 MAGSTIM
K871338 · Novametrix Medical Systems, Inc. · Aug 1987