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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K926410
Device Name ULTRATONE 8+ & 20
Applicant
Bowater Research, Inc.
49 N. Lake Ave.
Fox Lake,  IL  60020
Applicant Contact HERMAN F SCHAEFER
Correspondent
Bowater Research, Inc.
49 N. Lake Ave.
Fox Lake,  IL  60020
Correspondent Contact HERMAN F SCHAEFER
Regulation Number890.5850
Classification Product Code
IPF  
Date Received12/21/1992
Decision Date 08/11/1993
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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