Cleared Traditional

K222502 - KLICK (VARIANTS: POWER

K222502 is an FDA 510(k) clearance for KLICK (VARIANTS: POWER, manufactured by Klaxon Mobility GmbH. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K222502 · Klaxon Mobility GmbH · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
120d
Days
Class 2
Risk

K222502 is an FDA 510(k) clearance for the KLICK (VARIANTS: POWER, RACE, MONSTER). Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Klaxon Mobility GmbH (Arnoldstein, AT). The FDA issued a Cleared decision on December 16, 2022 after a review of 120 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 Klaxon Mobility GmbH devices

FDA 510(k) Submission Details - K222502

510(k) Number K222502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2022
Decision Date December 16, 2022
Days to Decision 120 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
5d slower than avg
Panel avg: 115d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

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 220
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K222502.
Ki Power Tilt System
K201869 · Ki Mobility, LLC · Sep 2023
AMP by Method Mobility, AMP Plus (or +) by Method Mobility
K231032 · Method Mobility · May 2023
Electric Wheelchair
K223393 · Shanghai Bangbang Robotics Co., Ltd. · Mar 2023
Electrically Powered Wheelchair, Joy Rider
K220156 · Tung Keng Enterprise Co., Ltd. · Oct 2022
Electric Wheelchair, Model: 9000N
K221799 · Silver Fox Corporation Limited · Sep 2022
Electric Wheelchair
K220827 · Foshan Dahao Medical Technology Co., Ltd. · Jul 2022