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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 K902255
Device Name OMRON PULSE STIMULATOR MODEL HV-F05
Applicant
Omron Electronics, Inc.
1615 L St., NW
Suite 1200
Washington,  DC  20036
Applicant Contact TERRY G MAHN
Correspondent
Omron Electronics, Inc.
1615 L St., NW
Suite 1200
Washington,  DC  20036
Correspondent Contact TERRY G MAHN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received05/21/1990
Decision Date 10/31/1990
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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