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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 K211574
Device Name Extreme X8
Applicant
Magic Mobility
3 International Court
Scoreby,  AU 3179
Applicant Contact Alex Suen
Correspondent
Acknowledge Regulatory Strategies, LLC
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Michelle Rubin-Onur
Regulation Number890.3860
Classification Product Code
ITI  
Date Received05/21/2021
Decision Date 07/09/2021
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
Predetermined Change
Control Plan Authorized		 No
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