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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 K210920
Device Name iBOT Personal Mobility Device (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 Received03/29/2021
Decision Date 06/16/2021
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
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