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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K924515
Device Name ELECTRIC MOBILITY RASCAL
Applicant
Electric Mobility Corp.
1 Mobility Plaza
Sewell,  NJ  08080
Applicant Contact MICHAEL FLOWERS
Correspondent
Electric Mobility Corp.
1 Mobility Plaza
Sewell,  NJ  08080
Correspondent Contact MICHAEL FLOWERS
Regulation Number890.3800
Classification Product Code
INI  
Date Received09/04/1992
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
Recalls CDRH Recalls
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