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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 K883671
Device Name 805 POWER CHAIR CONVERSION SYSTEM
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 Number890.3860
Classification Product Code
ITI  
Date Received08/18/1988
Decision Date 09/13/1988
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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