Cleared Traditional

K944487 - ELECTRO-MESH SOCK

K944487 is the FDA 510(k) clearance for ELECTRO-MESH SOCK by Prizm Medical, Inc.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K944487 · Prizm Medical, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Feb 1995
Decision
161d
Days
Class 2
Risk

K944487 is an FDA 510(k) clearance for the ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Prizm Medical, Inc. (Norcross, US). The FDA issued a Cleared decision on February 21, 1995 after a review of 161 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.

View all Prizm Medical, Inc. devices

Submission Details

510(k) Number K944487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1994
Decision Date February 21, 1995
Days to Decision 161 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
13d slower than avg
Panel avg: 148d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 118
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K944487.
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K944603 · Conmedcorp · Dec 1994
CONMED VERSA-STIM NEUROMUSCULAR STIMULATION ELECTRODE
K936101 · Conmedcorp · Jun 1994
CONMED VERSA-STIM INTERFERENTIAL ELECTRODE
K940704 · Conmedcorp · Jun 1994