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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 K981558
Device Name MYCYCLE HANDMASTER, LIGHT
Applicant
Richvale , Ltd.
885 N. Lasalle Blvd.
Chicago,  IL  60610
Applicant Contact SUSAN MAYS
Correspondent
Richvale , Ltd.
885 N. Lasalle Blvd.
Chicago,  IL  60610
Correspondent Contact SUSAN MAYS
Regulation Number890.3850
Classification Product Code
IOR  
Date Received05/01/1998
Decision Date 07/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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