Cleared Traditional

K010638 - NEUROPLUS, MODEL A10040, A10041, A10042, A10043

K010638 is an FDA 510(k) clearance for NEUROPLUS, manufactured by Vermont Medical, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K010638 · Vermont Medical, Inc. · Neurology device
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May 2001
Decision
59d
Days
Class 2
Risk

K010638 is an FDA 510(k) clearance for the NEUROPLUS, MODEL A10040, A10041, A10042, A10043. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Vermont Medical, Inc. (Bellows Falls, US). The FDA issued a Cleared decision on May 3, 2001 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K010638

510(k) Number K010638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2001
Decision Date May 03, 2001
Days to Decision 59 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
90d faster than avg
Panel avg: 149d · This submission: 59d
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 K010638.
LEAD-LOK REUSABLE TENS/ NMES ELECTRODES
K010431 · Lead-Lok, Inc. · Sep 2001
SELF-ADHESIVE ELECTRODES
K011411 · Pain Management Technologies · Jun 2001
KM-30 TENS ELECTRODE
K010543 · Katecho, Inc. · May 2001
WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE
K002219 · Wandy Rubber Industrial Co., Ltd. · Feb 2001
WANDY SILICONE CONDUCTIVE RUBBER PAD
K002227 · Wandy Rubber Industrial Co., Ltd. · Feb 2001
SOFTSENS
K001521 · Integrated Biosensing Technologies · Nov 2000
K010638 · NEUROPLUS, MODEL A10040, A10041, A10042, A10043
Download PDF Vermont Medical, Inc.