Cleared Traditional

K831785 - NEURO EASE

K831785 is an FDA 510(k) clearance for NEURO EASE, manufactured by Andover Medical, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K831785 · Andover Medical, Inc. · Neurology device
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Jun 1983
Decision
27d
Days
Class 2
Risk

K831785 is an FDA 510(k) clearance for the NEURO EASE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Andover Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 27 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.

View all Andover Medical, Inc. devices

FDA 510(k) Submission Details - K831785

510(k) Number K831785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1983
Decision Date June 30, 1983
Days to Decision 27 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 148d · This submission: 27d
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 236
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K831785.
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