Cleared Traditional

K192216 - Invacare AVIVA FX Power Wheelchair

K192216 is the FDA 510(k) clearance for Invacare AVIVA FX Power Wheelchair by Invacare Corporation. It is a Class 2 Physical Medicine device (product code ITI) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K192216 · Invacare Corporation · Physical Medicine device
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Jan 2020
Decision
140d
Days
Class 2
Risk

K192216 is an FDA 510(k) clearance for the Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Invacare Corporation (Elyria, US). The FDA issued a Cleared decision on January 2, 2020 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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 Invacare Corporation devices

Submission Details

510(k) Number K192216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2019
Decision Date January 02, 2020
Days to Decision 140 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
25d slower than avg
Panel avg: 115d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ITI Wheelchair, Powered

All 172
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K192216.
BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair
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Solax Powered Wheelchair (Models: S7101, S7103)
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Solax Powered Wheelchair
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Bariatric Power Positioning System (BPPS)
K182995 · Motion Concepts · Mar 2019
Wu's Powered Wheelchair
K181163 · Wu'S Tech Co., Ltd. · Feb 2019