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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 K003449
Device Name E MOTION WHEELCHAIR DRIVE SYSTEM (POWER-ASSIST FOR MANUAL WHEELCHAIRS)
Applicant
ULRICH ALBER GMBH & CO.
55 NORTHERN BLVD.
GREAT NECK,  NY  12020
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
ULRICH ALBER GMBH & CO.
55 NORTHERN BLVD.
GREAT NECK,  NY  12020
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number890.3860
Classification Product Code
ITI  
Date Received11/07/2000
Decision Date 03/16/2001
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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