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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 K972370
Device Name RASCAL POWER CHAIR
Applicant
Electric Mobility Corp.
1 Mobility Plaza
Sewell,  NJ  08080
Applicant Contact LEE J FALGOUST
Correspondent
Electric Mobility Corp.
1 Mobility Plaza
Sewell,  NJ  08080
Correspondent Contact LEE J FALGOUST
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/25/1997
Decision Date 11/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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