Cleared Traditional

K940012 - SMARTBRACE ELECTRODE

K940012 is an FDA 510(k) clearance for SMARTBRACE ELECTRODE, manufactured by Medical Devices, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K940012 · Medical Devices, Inc. · Neurology device
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Dec 1994
Decision
335d
Days
Class 2
Risk

K940012 is an FDA 510(k) clearance for the SMARTBRACE ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Medical Devices, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 5, 1994 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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. Elevated predicate reliance profile. 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 - K940012

510(k) Number K940012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1994
Decision Date December 05, 1994
Days to Decision 335 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
187d slower than avg
Panel avg: 148d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 156
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K940012.
EEG CUP ELECTRODE
K933808 · Cadwell Laboratories, Inc. · Dec 1994
RING ELECTRODE
K933805 · Cadwell Laboratories, Inc. · Dec 1994
CONMED VERSA STEM NEUROMUSCULAR STIMULATION/TENS
K944603 · Conmedcorp · Dec 1994
ELECTROFLEX
K943126 · Medical Devices, Inc. · Dec 1994
ELECTRODE, CUTANEOUS
K933801 · Cadwell Laboratories, Inc. · Oct 1994
CUTANEOUS ELECTRODE
K933802 · Cadwell Laboratories, Inc. · Sep 1994