Cleared Traditional

K882253 - STOUTE'S ASSIST-SEAT WHEELCHAIR COMPONENT

K882253 is an FDA 510(k) clearance for STOUTE'S ASSIST-SEAT WHEELCHAIR COMPONENT, manufactured by Stoute'S "Assist-Seat" Corp.. The device is a Class 1 Physical Medicine device with product code KNN cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K882253 · Stoute'S "Assist-Seat" Corp. · Physical Medicine device
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Jun 1988
Decision
27d
Days
Class 1
Risk

K882253 is an FDA 510(k) clearance for the STOUTE'S ASSIST-SEAT WHEELCHAIR COMPONENT. Classified as Components, Wheelchair (product code KNN), Class I - General Controls.

Submitted by Stoute'S "Assist-Seat" Corp. (Bronx, US). The FDA issued a Cleared decision on June 27, 1988 after a review of 27 days - a notably fast clearance cycle.

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: 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 Stoute'S "Assist-Seat" Corp. devices

FDA 510(k) Submission Details - K882253

510(k) Number K882253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1988
Decision Date June 27, 1988
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

KNN Device Classification - Class 1, General Controls

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 12
Devices cleared under the same product code (KNN) and FDA review panel - the closest regulatory comparables to K882253.
KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
K211919 · Kinetic Innovative Seating System, LLC · Mar 2022
CUSHION, WHELCHAR AND FLOTATION
K915629 · Invacare Corp. · Jan 1992
LIFESTYLE SOF. CARE GEL CHAIR CUSHION
K882012 · Gaymar Industries, Inc. · May 1988
VAN-TEC PROSTATE BIOPSY NEEDLE
K870698 · Van-Tec, Inc. · Mar 1987
(ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE
K863385 · Cook Urological, Inc. · Nov 1986
WHEELCHAIR ACCESSORIES
K840629 · Poirier S.A. · Feb 1984