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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 K885104
Device Name LAYDOWN ARM SUPPORT MECHANISM
Applicant
Rolcontrol Products, Co., Inc.
330 N.Wood Rd. Suite I
Camarillo,  CA  93010
Applicant Contact KEITH M HUSS
Correspondent
Rolcontrol Products, Co., Inc.
330 N.Wood Rd. Suite I
Camarillo,  CA  93010
Correspondent Contact KEITH M HUSS
Regulation Number890.3920
Classification Product Code
KNN  
Date Received12/12/1988
Decision Date 12/27/1988
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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