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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 K954427
Device Name HELPING HAND
Applicant
KINETIC REHABILITATION INSTRUMENTS, INC.
601 13TH STREET, N.W.
SUITE 500 NORTH
WASHINGTON,  DC  20005
Applicant Contact TERRY G MAHN
Correspondent
KINETIC REHABILITATION INSTRUMENTS, INC.
601 13TH STREET, N.W.
SUITE 500 NORTH
WASHINGTON,  DC  20005
Correspondent Contact TERRY G MAHN
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/22/1995
Decision Date 09/16/1996
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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