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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 K874843
Device Name VITALON MASSAGER
Applicant
Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd.
1-2-1-309 Ebisu-Nishi
Shibuya-Ku, Tokyo
Japan 150,  ID
Applicant Contact EIICHI YAMAMOTO
Correspondent
Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd.
1-2-1-309 Ebisu-Nishi
Shibuya-Ku, Tokyo
Japan 150,  ID
Correspondent Contact EIICHI YAMAMOTO
Regulation Number890.5660
Classification Product Code
ISA  
Date Received11/24/1987
Decision Date 01/20/1988
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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