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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 K955250
Device Name QI GONG MASSAGER
Applicant
East Health Development Group, Inc.
P.O. Box 947
Tustin,  CA  92680
Applicant Contact XIAOMING WANG
Correspondent
East Health Development Group, Inc.
P.O. Box 947
Tustin,  CA  92680
Correspondent Contact XIAOMING WANG
Regulation Number890.5975
Classification Product Code
IRO  
Date Received11/13/1995
Decision Date 02/08/1996
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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