FDA 510(k) Application Details - K240267

Device Classification Name Wheelchair, Powered

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510(K) Number K240267
Device Name Wheelchair, Powered
Applicant KLAXON Mobility GmbH
Industriestrasse,1
Arnoldstein 9601 AT
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Contact Riccardo Colomba
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 01/31/2024
Decision Date 01/10/2025
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240267


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