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KLICK (Variants: Power, Race, Monster)

by Klaxon Mobility GmbH

510(k) K222502

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222502↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK222502 Date16 Dec 2022ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
ITI
Device Class
Class II
Regulation
21 CFR Part 890.3860
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The KLICK is a Powered Wheelchair, classified under FDA code 2027797 and 8030931, designed for mobility assistance. It is engineered to provide active users with adjustable power features, including variable speed control and ergonomic seating options, to enhance independence and comfort in both indoor and outdoor environments. The device is categorized under the Physical Medicine specialty, reflecting its role in supporting functional mobility for individuals with limited mobility.

The KLICK variants (Power, Race, Monster) are supplied as reusable medical devices, intended for clinical or home use. Each variant is regulated under FDA 510K clearance and MDR, ensuring compliance with safety and performance standards. The devices are not MRI-safe and require proper storage in a clean, dry environment to maintain functionality. No single-use or sterilization requirements are specified, and sizing is tailored to user-specific needs as per manufacturer specifications.

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