Cleared Traditional

K963475 - PONCHO VEST RESTRAINT

K963475 is an FDA 510(k) clearance for PONCHO VEST RESTRAINT, manufactured by Deroyal Industries, Inc.. The device is a Class 1 Physical Medicine device with product code KID cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K963475 · Deroyal Industries, Inc. · Physical Medicine device
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Jan 1997
Decision
141d
Days
Class 1
Risk

K963475 is an FDA 510(k) clearance for the PONCHO VEST RESTRAINT. 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

FDA 510(k) Submission Details - K963475

510(k) Number K963475 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 115d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

KID Device Classification - Class 1, General Controls

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.

Regulatory Peers - KID Restraint, Wheelchair, Non-protective

Devices cleared under the same product code (KID) and FDA review panel - the closest regulatory comparables to K963475.
WHEELCHAIR BELT
K963479 · Deroyal Industries, Inc. · Jan 1997
MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER
K963480 · Deroyal Industries, Inc. · Jan 1997
SUPPORT VEST
K963459 · Skil-Care Corp. · Oct 1996
SAFETY PONCHO/SHOULDER STRAP PONCHO
K963461 · Skil-Care Corp. · Oct 1996
SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL
K963455 · Skil-Care Corp. · Oct 1996