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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 K213090
Device Name Frontier Series Power Wheelchairs
Applicant
Magic Mobility
3 International Court
Scoreby,  AU 3179
Applicant Contact Jill Mckechnie
Correspondent
Acknowledge Regulatory Strategies, LLC
2251 San Diego Avenue, Suite B-257
San Diego,  CA  92110
Correspondent Contact Matthieu Kirkland
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/24/2021
Decision Date 11/19/2021
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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