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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 K181908
Device Name Action Trackchair
Applicant
Action Manufacturing Inc.
1105 Lake Road
Marshall,  MN  56258
Applicant Contact Alan Macht
Correspondent
Action Manufacturing Inc.
1105 Lake Road
P.O. Box 620
Marshall,  MN  56258
Correspondent Contact Alan Macht
Regulation Number890.3860
Classification Product Code
ITI  
Date Received07/17/2018
Decision Date 12/03/2018
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
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