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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 K932786
FOIA Releasable 510(k) K932786
Device Name UCS 1000(TM) WITH TONGUETOUCH KEYPAD WHEELCHAIR
Applicant
New Abilities Systems, Inc.
470 San Antonio Rd., Suite G
Mount View,  CA  94306
Applicant Contact ROBERT G JAGUNICH
Correspondent
New Abilities Systems, Inc.
470 San Antonio Rd., Suite G
Mount View,  CA  94306
Correspondent Contact ROBERT G JAGUNICH
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/09/1993
Decision Date 03/28/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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