FDA 510(k) Application Details - K242430

Device Classification Name Wheelchair, Powered

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510(K) Number K242430
Device Name Wheelchair, Powered
Applicant Soul Mobility
659 River Bluff Circle
Oconomowoc, WI 53066 US
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Contact Troy Tesmer
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 08/15/2024
Decision Date 11/12/2024
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 K242430


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