Cleared Traditional

K030800 - ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES

K030800 is an FDA 510(k) clearance for ELECTROMED REUSABLE NEUROSTIMULATION EL..., manufactured by Eletromed, 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.

K030800 · Eletromed, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
90d
Days
Class 2
Risk

K030800 is an FDA 510(k) clearance for the ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Eletromed, Inc. (Betheda, US). The FDA issued a Cleared decision on June 11, 2003 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.

FDA 510(k) Submission Details - K030800

510(k) Number K030800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2003
Decision Date June 11, 2003
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 149d · 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 439
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K030800.
AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE
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K030564 · United Pacific, Inc. · Sep 2003
SOFT-TOUCH TENS ELECTRODE
K030375 · Pain Management Technologies · May 2003
FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130
K030297 · Enraf-Nonius, B.V. · Apr 2003
HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES
K022917 · Home Care Technology Co., Ltd. · Mar 2003
K030800 · ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES
Download PDF FDA Summary Eletromed, Inc.