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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Standup
510(k) Number K202728
Device Name Action Trackchair Hawk
Applicant
Action Manufacturing, Inc.
1105 Lake Rd.
Marshall,  MN  56258
Applicant Contact Alan Macht
Correspondent
Action Manufacturing, Inc.
1105 Lake Rd.
Marshall,  MN  56258
Correspondent Contact Alan Macht
Regulation Number890.3900
Classification Product Code
IPL  
Date Received09/18/2020
Decision Date 02/10/2022
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
Predetermined Change
Control Plan Authorized		 No
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