Cleared Traditional

K001117 - COMFORT STIM

K001117 is an FDA 510(k) clearance for COMFORT STIM, manufactured by R & D Medical Products, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K001117 · R & D Medical Products, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
90d
Days
Class 2
Risk

K001117 is an FDA 510(k) clearance for the COMFORT STIM. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by R & D Medical Products, Inc. (Lake Forest, US). The FDA issued a Cleared decision on July 5, 2000 after a review of 90 days - within the typical 510(k) review window.

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 R & D Medical Products, Inc. devices

FDA 510(k) Submission Details - K001117

510(k) Number K001117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2000
Decision Date July 05, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
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 232
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K001117.
KM-10 TENS ELECTRODE
K000870 · Katecho, Inc. · Nov 2000
ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110
K001980 · Aspect Medical Systems, Inc. · Sep 2000
ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106
K002734 · Aspect Medical Systems, Inc. · Sep 2000
MODEL 4300 PSARRAY EEG ELECTRODE SET
K001055 · Physiometrix, Inc. · May 2000
ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
K994330 · Aspect Medical Systems, Inc. · Jan 2000
AQUABOND ELECTRODE
K964433 · Medibond , Ltd. · Jan 1997