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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K250819
Device Name Electric Wheelchair (Rollz Motion Electric 2M)
Applicant
Rollz International BV
Rotterdamseweg 402 M, 2629hh
Delft,  NL
Applicant Contact Martijn Schaaper
Correspondent
Rollz International BV
Rotterdamseweg 402 M, 2629hh
Delft,  NL
Correspondent Contact Martijn Schaaper
Regulation Number890.3860
Classification Product Code
ITI  
Date Received03/18/2025
Decision Date 11/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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