Cleared Traditional

K801489 - EZ ON SAFETY PONCHO

K801489 is the FDA 510(k) clearance for EZ ON SAFETY PONCHO by Skil-Care Corp.. It is a Class 1 Physical Medicine device (product code KNO) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K801489 · Skil-Care Corp. · Physical Medicine device
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Jul 1980
Decision
18d
Days
Class 1
Risk

K801489 is an FDA 510(k) clearance for the EZ ON SAFETY PONCHO. Classified as Accessories, Wheelchair (product code KNO), Class I - General Controls.

Submitted by Skil-Care Corp. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1980 after a review of 18 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Skil-Care Corp. devices

Submission Details

510(k) Number K801489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1980
Decision Date July 14, 1980
Days to Decision 18 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 115d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KNO Accessories, Wheelchair
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 - KNO Accessories, Wheelchair

All 31
Devices cleared under the same product code (KNO) and FDA review panel - the closest regulatory comparables to K801489.
BODY STRAP
K810439 · Fred Sammons, Inc. · Mar 1981
WHEELCHAIR ACCESSORIES
K810448 · Fred Sammons, Inc. · Mar 1981
BK-5058-01 QUAD-QUIP WHEELCHAIR CUFF
K801709 · Fred Sammons, Inc. · Aug 1980
HAMILTON TUCKAWAY DESK
K801214 · Orthopedic Systems, Inc. · May 1980
ADJUSTABLE HEIGHT DESK ARM LAP TRAY KIT
K790176 · Fred Sammons, Inc. · Feb 1979
ASHTRAY FOR WHEELCHAIR
K790177 · Fred Sammons, Inc. · Feb 1979