Cleared Traditional

K963480 - MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER (FDA 510(k) Clearance)

Class I Physical Medicine device.

K963480 · Deroyal Industries, Inc. · Physical Medicine device
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Jan 1997
Decision
141d
Days
Class 1
Risk

K963480 is an FDA 510(k) clearance for the MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER. Classified as Restraint, Wheelchair, Non-protective (product code KID), Class I - General Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3910 - 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 Deroyal Industries, Inc. devices

Submission Details

510(k) Number K963480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date January 22, 1997
Days to Decision 141 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
26d slower than avg
Panel avg: 115d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KID Restraint, Wheelchair, Non-protective
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3910
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.