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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, Electric
510(k) Number K893029
Device Name OMRON TRAVEL MASSAGER, MODEL HM-01
Applicant
Omron Electronics, Inc.
One E. Commerce Dr.
Schaumburg,  IL  60173
Applicant Contact OISHI
Correspondent
Omron Electronics, Inc.
One E. Commerce Dr.
Schaumburg,  IL  60173
Correspondent Contact OISHI
Regulation Number890.5660
Classification Product Code
ISA  
Date Received04/24/1989
Decision Date 05/31/1989
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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