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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K031546
Device Name RAINBOW GT-4A PAIN RELIEF MACHINE
Applicant
Sino-Us Information, Inc.
85-13 88th Ave.
Woodhaven,  NY  11421
Applicant Contact YITANG SHENG
Correspondent
Sino-Us Information, Inc.
85-13 88th Ave.
Woodhaven,  NY  11421
Correspondent Contact YITANG SHENG
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/16/2003
Decision Date 11/13/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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