Cleared Traditional

K943929 - DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)

K943929 is an FDA 510(k) clearance for DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM ..., manufactured by Greenleaf Medical Systems, Inc.. The device is a Class 1 Neurology device with product code KQX cleared through the Traditional 510(k) pathway after a 276-day FDA review.

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

FDA 510(k) Submission Details - K943929

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.

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 10
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