Cleared Traditional

K935017 - TD50 ELECTROMYOGRAPH

K935017 is an FDA 510(k) clearance for TD50 ELECTROMYOGRAPH, manufactured by Medelec Intl. Corp.. The device is a Class 2 Neurology device with product code JXE cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K935017 · Medelec Intl. Corp. · Neurology device
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Jul 1994
Decision
282d
Days
Class 2
Risk

K935017 is an FDA 510(k) clearance for the TD50 ELECTROMYOGRAPH. Classified as Device, Nerve Conduction Velocity Measurement (product code JXE), Class II - Special Controls.

Submitted by Medelec Intl. Corp. (England, GB). The FDA issued a Cleared decision on July 28, 1994 after a review of 282 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1550 - 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 Medelec Intl. Corp. devices

FDA 510(k) Submission Details - K935017

510(k) Number K935017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1993
Decision Date July 28, 1994
Days to Decision 282 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 148d · This submission: 282d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXE Device Classification - Class 2, Special Controls

Product Code JXE Device, Nerve Conduction Velocity Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1550
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 - JXE Device, Nerve Conduction Velocity Measurement

All 15
Devices cleared under the same product code (JXE) and FDA review panel - the closest regulatory comparables to K935017.
MODIFICATION TO NC-STAT
K000565 · Neurometrix, Inc. · Jun 2000
NC-STAT
K982359 · Neurometrix, Inc. · Oct 1998
NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)
K963208 · Neurotron Medical · Jul 1997
REUSABLE DUAL DISC BAR RECORDING ELECTRODES
K923665 · Chalgren Enterprises, Inc. · Oct 1992
REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS
K921504 · Chalgren Enterprises, Inc. · Sep 1992
CADWELL 5200
K820031 · Cadwell Laboratories, Inc. · Feb 1982