Cleared Traditional

K915629 - CUSHION

K915629 is an FDA 510(k) clearance for CUSHION, manufactured by Invacare Corp.. The device is a Class 1 Physical Medicine device with product code KNN cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K915629 · Invacare Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
23d
Days
Class 1
Risk

K915629 is an FDA 510(k) clearance for the CUSHION, WHELCHAR AND FLOTATION. Classified as Components, Wheelchair (product code KNN), Class I - General Controls.

Submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on January 9, 1992 after a review of 23 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 Invacare Corp. devices

FDA 510(k) Submission Details - K915629

510(k) Number K915629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1991
Decision Date January 09, 1992
Days to Decision 23 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
92d faster than avg
Panel avg: 115d · This submission: 23d
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 10
Devices cleared under the same product code (KNN) and FDA review panel - the closest regulatory comparables to K915629.
KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
K211919 · Kinetic Innovative Seating System, LLC · Mar 2022
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
ARM THROUGH FOR WHEELCHAIR BK-6458-01
K823637 · Fred Sammons, Inc. · Jan 1983
ARM THROUGH FOR WHEELCHAIR BK 6454-01 &
K823638 · Fred Sammons, Inc. · Jan 1983