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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 K945603
Device Name CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES)
Applicant
Headwaters, Inc.
10 Rogers St., Suite 214
Cambridge,  MA  02142
Applicant Contact RUDY A VANDENBELT
Correspondent
Headwaters, Inc.
10 Rogers St., Suite 214
Cambridge,  MA  02142
Correspondent Contact RUDY A VANDENBELT
Regulation Number890.5975
Classification Product Code
IRO  
Date Received11/15/1994
Decision Date 02/09/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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