Cleared Traditional

IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1) (K964977) - FDA 510(k) Clearance

Class I Physical Medicine device.

K964977 · Interactive Living Systems, Inc. · Physical Medicine device
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Aug 1998
Decision
627d
Days
Class 1
Risk

K964977 is an FDA 510(k) clearance for the IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1). Classified as Unit, Activation, Breath Control (product code LFF), Class I - General Controls.

Submitted by Interactive Living Systems, Inc. (Aurora, US). The FDA issued a Cleared decision on August 31, 1998 after a review of 627 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3920 - the FDA physical medicine 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Interactive Living Systems, Inc. devices

Submission Details

510(k) Number K964977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1996
Decision Date August 31, 1998
Days to Decision 627 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
512d slower than avg
Panel avg: 115d · This submission: 627d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFF Unit, Activation, Breath Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3920
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.