Cleared Traditional

K911366 - PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE

K911366 is an FDA 510(k) clearance for PROTECTOR DISPOSABLE TENS AND NMES ELEC..., manufactured by Medical Design & Manufacturing Corp.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K911366 · Medical Design & Manufacturing Corp. · Neurology device
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Sep 1991
Decision
183d
Days
Class 2
Risk

K911366 is an FDA 510(k) clearance for the PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Medical Design & Manufacturing Corp. (Westerville, US). The FDA issued a Cleared decision on September 27, 1991 after a review of 183 days - an extended review cycle.

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. 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 Design & Manufacturing Corp. devices

FDA 510(k) Submission Details - K911366

510(k) Number K911366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1991
Decision Date September 27, 1991
Days to Decision 183 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 148d · This submission: 183d
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 317
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K911366.
ELECTRODE
K912643 · Skylark Device Co., Ltd. · Feb 1992
K-STIM
K913031 · Katecho, Inc. · Jan 1992
ELECTRODE USING PROMEON RG-60 SERIES GEL
K915333 · Labeltape Meditect, Inc. · Jan 1992
VERSA-STIM ELECTRODE LINE MODIFIED
K911069 · Conmedcorp · Jul 1991
3M 6830 ELECTRODE
K905539 · 3M Healthcare · May 1991
NORTECH MODEL 86901000 ELECTRODE
K903427 · Andover Medical, Inc. · Aug 1990