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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 K920487
Device Name MINI VIBRATOR
Applicant
Alimed, Inc.
297 High St.
Dedham,  MA  02026
Applicant Contact JONATHAN C BERTZ
Correspondent
Alimed, Inc.
297 High St.
Dedham,  MA  02026
Correspondent Contact JONATHAN C BERTZ
Regulation Number890.5975
Classification Product Code
IRO  
Date Received01/30/1992
Decision Date 02/18/1992
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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