Cleared Traditional

K933063 - ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA (FDA 510(k) Clearance)

Class I Neurology device.

K933063 · Isotechnologies, Inc. · Neurology device
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Jan 1994
Decision
219d
Days
Class 1
Risk

K933063 is an FDA 510(k) clearance for the ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA. Classified as Goniometer, Ac-powered (product code KQX), Class I - General Controls.

Submitted by Isotechnologies, Inc. (Hillsborough, US). The FDA issued a Cleared decision on January 27, 1994 after a review of 219 days - an extended review cycle.

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 Isotechnologies, Inc. devices

Submission Details

510(k) Number K933063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1993
Decision Date January 27, 1994
Days to Decision 219 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
71d slower than avg
Panel avg: 148d · This submission: 219d
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.