FDA 510(k) Application Details - K243442

Device Classification Name Wheelchair, Stair Climbing

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510(K) Number K243442
Device Name Wheelchair, Stair Climbing
Applicant Mobius Mobility
540 Commercial St. Suite 310
Manchester, NH 03101 US
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Contact Joseph Sullivan
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Regulation Number 890.3890

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Classification Product Code IMK
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Date Received 11/06/2024
Decision Date 01/30/2025
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 K243442


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