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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 K950322
Device Name RELAXY-THE WONDER HAND
Applicant
Kinsei Shiatsu, Inc.
22138 S. Vermont Ave.
Unit F
Torrance,  CA  90502
Applicant Contact KOJI NISHIDA
Correspondent
Kinsei Shiatsu, Inc.
22138 S. Vermont Ave.
Unit F
Torrance,  CA  90502
Correspondent Contact KOJI NISHIDA
Regulation Number890.5660
Classification Product Code
ISA  
Date Received01/26/1995
Decision Date 02/14/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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