Cleared Traditional

K935853 - EMG TRAINER

K935853 is an FDA 510(k) clearance for EMG TRAINER, manufactured by Unitech. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 406-day FDA review.

K935853 · Unitech · Neurology device
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Jan 1995
Decision
406d
Days
Class 2
Risk

K935853 is an FDA 510(k) clearance for the EMG TRAINER. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Unitech (Madison, US). The FDA issued a Cleared decision on January 18, 1995 after a review of 406 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Unitech devices

FDA 510(k) Submission Details - K935853

510(k) Number K935853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1993
Decision Date January 18, 1995
Days to Decision 406 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
258d slower than avg
Panel avg: 148d · This submission: 406d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 - HCC Device, Biofeedback

All 57
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K935853.
DIGITAL CONDUCTANCE METER
K924313 · The Jayms Co. · Mar 1996
ORALSENSOR
K953257 · Cycura Corp. · Feb 1996
J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS
K945826 · Medical Device Inspection Co., Inc. · Aug 1995
MYOTRAC2
K915858 · Thought Technology , Ltd. · Sep 1992
MYOTRAC/S, MYODAC/S
K915859 · Thought Technology , Ltd. · Sep 1992
MYOTRAC+/S, MYODAC+/S
K913898 · Thought Technology , Ltd. · Mar 1992