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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K222502
Device Name KLICK (VARIANTS: POWER, RACE, MONSTER)
Applicant
Klaxon Mobility GmbH
Industriesrasse, 1
Arnoldstein,  AT 9601
Applicant Contact Riccardo Colomba
Correspondent
Klaxon Mobility GmbH
Industriesrasse, 1
Arnoldstein,  AT 9601
Correspondent Contact Riccardo Colomba
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/18/2022
Decision Date 12/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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