Cleared Traditional

K010431 - LEAD-LOK REUSABLE TENS/ NMES ELECTRODES

K010431 is an FDA 510(k) clearance for LEAD-LOK REUSABLE TENS/ NMES ELECTRODES, manufactured by Lead-Lok, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K010431 · Lead-Lok, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
205d
Days
Class 2
Risk

K010431 is an FDA 510(k) clearance for the LEAD-LOK REUSABLE TENS/ NMES ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Lead-Lok, Inc. (Sandpoint, US). The FDA issued a Cleared decision on September 6, 2001 after a review of 205 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.

FDA 510(k) Submission Details - K010431

510(k) Number K010431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2001
Decision Date September 06, 2001
Days to Decision 205 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
56d slower than avg
Panel avg: 149d · This submission: 205d
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 K010431.
KIMSTIM AURICULAR ELECTRODE
K011691 · Kim Institute For Rehabilitation Medicine, P.C. · Dec 2001
MODIFICATION TO:APEX MEDICAL IF-4100
K013813 · Apex Medical Corp. · Dec 2001
COM-PATCH
K012140 · Apex Medical Corp. · Oct 2001
SELF-ADHESIVE ELECTRODES
K011411 · Pain Management Technologies · Jun 2001
KM-30 TENS ELECTRODE
K010543 · Katecho, Inc. · May 2001
NEUROPLUS, MODEL A10040, A10041, A10042, A10043
K010638 · Vermont Medical, Inc. · May 2001
K010431 · LEAD-LOK REUSABLE TENS/ NMES ELECTRODES
Download PDF FDA Summary Lead-Lok, Inc.