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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vibrator, Therapeutic
510(k) Number K952916
Device Name SHIATSU MASTER MASSAGER CUSHION
Applicant
Kinsei Shiatsu, Inc.
22138 S. Vermont Ave.
Unit F
Torrance,  CA  90502
Applicant Contact HARU ISHIMOTO
Correspondent
Kinsei Shiatsu, Inc.
22138 S. Vermont Ave.
Unit F
Torrance,  CA  90502
Correspondent Contact HARU ISHIMOTO
Regulation Number890.5975
Classification Product Code
IRO  
Date Received06/26/1995
Decision Date 08/28/1995
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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