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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vibrator, Therapeutic
510(k) Number K912659
Device Name SOUND RELIEF
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 Number890.5975
Classification Product Code
IRO  
Date Received06/17/1991
Decision Date 09/06/1991
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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