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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K253762
Device Name ErgoSteel (ES0001/696)
Applicant
Strongback Mobility AG C/O Blueaudit GmbH
Schindellegistrasse 73
Pfaeffikon,  CH 8808
Applicant Contact Roman Hefle
Correspondent
Strongback Mobility AG C/O Blueaudit GmbH
Schindellegistrasse 9
Wolfhagen,  DE 34466
Correspondent Contact Roman Hefle
Regulation Number890.3850
Classification Product Code
IOR  
Date Received11/25/2025
Decision Date 09/22/2026
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
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