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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 K915230
Device Name H WAVE MUSCLE STIMULATOR
Applicant
Electronic Waveform Laboratory, Inc.
15683 Chemical Ln.
Huntington Beach,  CA  92649
Applicant Contact JIM HEANEY
Correspondent
Electronic Waveform Laboratory, Inc.
15683 Chemical Ln.
Huntington Beach,  CA  92649
Correspondent Contact JIM HEANEY
Regulation Number890.5850
Classification Product Code
IPF  
Date Received11/20/1991
Decision Date 05/08/1992
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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