Cleared Traditional

DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS) (K943929) - FDA 510(k) Clearance

Class I Neurology device.

K943929 · Greenleaf Medical Systems, Inc. · Neurology device
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May 1995
Decision
276d
Days
Class 1
Risk

K943929 is an FDA 510(k) clearance for the DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS). Classified as Goniometer, Ac-powered (product code KQX), Class I - General Controls.

Submitted by Greenleaf Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on May 15, 1995 after a review of 276 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 Greenleaf Medical Systems, Inc. devices

Submission Details

510(k) Number K943929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1994
Decision Date May 15, 1995
Days to Decision 276 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
128d slower than avg
Panel avg: 148d · This submission: 276d
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.