Cleared Traditional

K971079 - INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE

K971079 is an FDA 510(k) clearance for INTERLOGICS W-TRACKER AND WRIST WORKS S..., manufactured by Interlogics, Inc.. The device is a Class 1 Neurology device with product code KQX cleared through the Traditional 510(k) pathway after a 106-day FDA review.

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.

FDA 510(k) Submission Details - K971079

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 149d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

KQX Device Classification - Class 1, General Controls

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.

Regulatory Peers - KQX Goniometer, Ac-powered

All 31
Devices cleared under the same product code (KQX) and FDA review panel - the closest regulatory comparables to K971079.
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K945630 · J-Tech, Inc. · May 1995
K971079 · INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE
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