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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Stair Climbing
510(k) Number K243442
Device Name iBOT® PMD
Applicant
Mobius Mobility
540 Commercial St. Suite 310
Manchester,  NH  03101
Applicant Contact Joseph Sullivan
Correspondent
Mobius Mobility
540 Commercial St. Suite 310
Manchester,  NH  03101
Correspondent Contact Joseph Sullivan
Regulation Number890.3890
Classification Product Code
IMK  
Subsequent Product Code
ITI  
Date Received11/06/2024
Decision Date 01/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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