Cleared Traditional

K211919 - KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat (FDA 510(k) Clearance)

Class I Physical Medicine device.

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

Submission Details

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.

Device Classification

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.