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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 K260295
Device Name Helio Kids; Apex P
Applicant
Motion Composites
160 Armand-Majeau Sud
Saint-Roch-Del’Achigan,  CA JOK 3H0
Applicant Contact Catherine Marquis
Correspondent
Motion Composites
160 Armand-Majeau Sud
Saint-Roch-Del’Achigan,  CA JOK 3H0
Correspondent Contact Catherine Marquis
Regulation Number890.3850
Classification Product Code
IOR  
Date Received01/29/2026
Decision Date 05/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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