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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, Electric
510(k) Number K904915
Device Name CARESS MASSAGER
Applicant
Kendex Corp.
P.O. Box 1909
Moorpark,  CA  93020
Applicant Contact KARLYN HALE
Correspondent
Kendex Corp.
P.O. Box 1909
Moorpark,  CA  93020
Correspondent Contact KARLYN HALE
Regulation Number890.5660
Classification Product Code
ISA  
Date Received10/31/1990
Decision Date 11/27/1990
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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