Cleared Traditional

INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE (K971079) - FDA 510(k) Clearance

Class I Neurology device.

K971079 · Interlogics, Inc. · Neurology device
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Jul 1997
Decision
106d
Days
Class 1
Risk

K971079 is an FDA 510(k) clearance for the INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE. Classified as Goniometer, Ac-powered (product code KQX), Class I - General Controls.

Submitted by Interlogics, Inc. (Hillsborough, US). The FDA issued a Cleared decision on July 9, 1997 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1500 - 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 Interlogics, Inc. devices

Submission Details

510(k) Number K971079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1997
Decision Date July 09, 1997
Days to Decision 106 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
42d faster than avg
Panel avg: 148d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KQX Goniometer, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.1500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.