Cleared Traditional

K211919 - KISS Dynamic Back Support

K211919 is an FDA 510(k) clearance for KISS Dynamic Back Support, manufactured by Kinetic Innovative Seating System, LLC. The device is a Class 1 Physical Medicine device with product code KNN cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K211919 · Kinetic Innovative Seating System, LLC · Physical Medicine device
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Mar 2022
Decision
256d
Days
Class 1
Risk

K211919 is an FDA 510(k) clearance for the KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat. Classified as Components, Wheelchair (product code KNN), Class I - General Controls.

Submitted by Kinetic Innovative Seating System, LLC (Branford, US). The FDA issued a Cleared decision on March 4, 2022 after a review of 256 days - an extended review 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: 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 Kinetic Innovative Seating System, LLC devices

FDA 510(k) Submission Details - K211919

510(k) Number K211919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2021
Decision Date March 04, 2022
Days to Decision 256 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
141d slower than avg
Panel avg: 115d · This submission: 256d
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 K211919.
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
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