Cleared Traditional

K881416 - MYOTRAC

K881416 is an FDA 510(k) clearance for MYOTRAC, manufactured by Thought Technology , Ltd.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K881416 · Thought Technology , Ltd. · Neurology device
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Sep 1988
Decision
175d
Days
Class 2
Risk

K881416 is an FDA 510(k) clearance for the MYOTRAC. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Thought Technology , Ltd. (Montreal, Quebec, CA). The FDA issued a Cleared decision on September 26, 1988 after a review of 175 days - an extended review cycle.

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: 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.

FDA 510(k) Submission Details - K881416

510(k) Number K881416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1988
Decision Date September 26, 1988
Days to Decision 175 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
26d slower than avg
Panel avg: 149d · This submission: 175d
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 172
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K881416.
BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1
K884853 · Moe · Feb 1989
DM100 (DISTAL MONITOR - 100)
K884135 · Bio.Logic, Inc. · Jan 1989
MYODAC
K883597 · Thought Technology , Ltd. · Nov 1988
DIGITAL EMG MONITOR MYOTRON 120
K882266 · Ats Co. · Aug 1988
MODEL BIOSTAR
K882062 · Targus Concepts · Jun 1988
M424 EMG MONITOR
K880913 · Bio-Logic Devices · May 1988
K881416 · MYOTRAC
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