FDA 510(k) Application Details - K213090

Device Classification Name Wheelchair, Powered

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510(K) Number K213090
Device Name Wheelchair, Powered
Applicant Magic Mobility
3 International Court
Scoreby 3179 AU
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Contact Jill Mckechnie
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 09/24/2021
Decision Date 11/19/2021
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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