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FDA 510(k) Application Details - K243442
Device Classification Name
Wheelchair, Stair Climbing
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
890.3890
More FDA Info for this Regulation Number
Classification Product Code
IMK
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More FDA Info for this Product Code
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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