Cleared Special

KLAXON (TWIST) (K250748) - FDA 510(k) Clearance

Also marketed or referenced as:
KLAXON (TWIST R)

Class II Physical Medicine device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K250748 · Klaxon Mobility GmbH · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
30d
Days
Class 2
Risk

K250748 is an FDA 510(k) clearance for the KLAXON (TWIST). 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 April 11, 2025 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Klaxon Mobility GmbH devices

Submission Details

510(k) Number K250748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2025
Decision Date April 11, 2025
Days to Decision 30 days
Submission Type Special
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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 170
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K250748.
Electric Wheelchair (F309)
K250758 · Changshu Pingfang Wheelchair Co., Ltd. · May 2025
eFOLDi Navigator Powerchair (STPC-A)
K243110 · Suntech UK , Ltd. · May 2025
Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003)
K250158 · Zhe Jiang Cleisman Industry and Trade Co.,Ltd · Apr 2025
Electric Wheelchair (LW01301A07)
K250366 · Anhui Longway Medical Technology Co., Ltd. · Apr 2025
Powered wheelchair (mobility robot) (M4, M4U)
K242358 · Xsto Co., Ltd. · Apr 2025
Electrically powered wheelchair
K244003 · Kunshan Hi-Fortune Health Products Co., Ltd. · Mar 2025