Cleared Traditional

K903161 - MC II (TM)

K903161 is an FDA 510(k) clearance for MC II (TM), manufactured by Medical Devices, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K903161 · Medical Devices, Inc. · Neurology device
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Mar 1991
Decision
252d
Days
Class 2
Risk

K903161 is an FDA 510(k) clearance for the MC II (TM), MODEL 7200S. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Medical Devices, Inc. (St. Paul, US). The FDA issued a Cleared decision on March 27, 1991 after a review of 252 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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 Medical Devices, Inc. devices

FDA 510(k) Submission Details - K903161

510(k) Number K903161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1990
Decision Date March 27, 1991
Days to Decision 252 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
104d slower than avg
Panel avg: 148d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 140
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K903161.
ELECTRO-NEVE STIMULATOR TENS MODEL BIOMED PLUS/A
K905230 · Biomedical Life Systems, Inc. · Jun 1991
ELECTRO-NERVE STIMULATOR TENS MODEL SYSTEMS 2000/A
K905377 · Biomedical Life Systems, Inc. · Jun 1991
ELECTRO-NERVE STIMULATOR TENS MODEL BIOMED 2000/A
K905570 · Biomedical Life Systems, Inc. · Jun 1991
SYNAPS (TM)
K903828 · Henley Intl. · Jan 1991
NEUROTENS
K896620 · Henley Intl. · Apr 1990
DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S
K895473 · Medical Devices, Inc. · Dec 1989