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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Components, Wheelchair
510(k) Number K900839
Device Name THE CAROLINA ROCKER
Applicant
Artec Environmental Monitoring Division
110 Stonehedge Dr.
Greenville,  SC  29615
Applicant Contact RANDOLPH E CREW
Correspondent
Artec Environmental Monitoring Division
110 Stonehedge Dr.
Greenville,  SC  29615
Correspondent Contact RANDOLPH E CREW
Regulation Number890.3920
Classification Product Code
KNN  
Date Received02/22/1990
Decision Date 04/18/1990
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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