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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 K862013
Device Name STANDING WHEELER
Applicant
Engineering Mechanics, Co.
P.O. Box 42808
Dept. 287
Houston,  TX  77042
Applicant Contact MICHAEL A FREEMAN
Correspondent
Engineering Mechanics, Co.
P.O. Box 42808
Dept. 287
Houston,  TX  77042
Correspondent Contact MICHAEL A FREEMAN
Regulation Number890.3900
Classification Product Code
IPL  
Date Received05/28/1986
Decision Date 07/08/1986
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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