Cleared Traditional

ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION (K933051) - FDA 510(k) Clearance

Class I Physical Medicine device.

K933051 · General Components Intl., Inc. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Oct 1993
Decision
140d
Days
Class 1
Risk

K933051 is an FDA 510(k) clearance for the ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION. Classified as Components, Wheelchair (product code KNN), Class I - General Controls.

Submitted by General Components Intl., Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 12, 1993 after a review of 140 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all General Components Intl., Inc. devices

Submission Details

510(k) Number K933051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1993
Decision Date October 12, 1993
Days to Decision 140 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 115d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KNN Components, Wheelchair
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.

Regulatory Peers - KNN Components, Wheelchair

All 63
Devices cleared under the same product code (KNN) and FDA review panel - the closest regulatory comparables to K933051.
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ARM THROUGH FOR WHEELCHAIR BK 6454-01 &
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DESK ARM WHEELCHAIR ARM EXTENSION
K812348 · Fred Sammons, Inc. · Sep 1981