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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 K891987
Device Name BIO-STYM 250 (MUSCLE STIMULATOR)
Applicant
Electronic Health Technologies, Inc.
2405 Ih 35 W
New Braunfels,  TX  78130
Applicant Contact JAMES B BINGHAM
Correspondent
Electronic Health Technologies, Inc.
2405 Ih 35 W
New Braunfels,  TX  78130
Correspondent Contact JAMES B BINGHAM
Regulation Number890.5850
Classification Product Code
IPF  
Date Received03/28/1989
Decision Date 01/04/1990
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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