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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stroller, Adaptive
510(k) Number K820591
Device Name MECHANICAL CHAIR
Applicant
Kaye Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Kaye Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3850
Classification Product Code
LBE  
Date Received03/04/1982
Decision Date 03/15/1982
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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