FDA 510(k) Application Details - K222502

Device Classification Name Wheelchair, Powered

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510(K) Number K222502
Device Name Wheelchair, Powered
Applicant KLAXON Mobility GmbH
Industriesrasse, 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 08/18/2022
Decision Date 12/16/2022
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



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