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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 K924237
Device Name WINDMERE PRELUDE III
Applicant
Windmere Corp.
5980 Miami Lades Dr.
Miami Lakes,  FL  33014
Applicant Contact DEE EICHENBERGER
Correspondent
Windmere Corp.
5980 Miami Lades Dr.
Miami Lakes,  FL  33014
Correspondent Contact DEE EICHENBERGER
Regulation Number890.5660
Classification Product Code
ISA  
Date Received08/24/1992
Decision Date 10/18/1993
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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