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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K943936
Device Name XLT, REA COMFORT, SPIREA, ZOOM
Applicant
Electric Mobility Corp.
1 Mobility Plz.
Sewell,  NJ  08080
Applicant Contact WAYNE R HATLEY
Correspondent
Electric Mobility Corp.
1 Mobility Plz.
Sewell,  NJ  08080
Correspondent Contact WAYNE R HATLEY
Regulation Number890.3850
Classification Product Code
IOR  
Date Received08/12/1994
Decision Date 09/21/1994
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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