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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 K982967
Device Name RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R
Applicant
Woodside Biomedical, Inc.
181 40 Smokesignal Dr.
San Diego,  CA  92127
Applicant Contact CAROL PATTERSON
Correspondent
Woodside Biomedical, Inc.
181 40 Smokesignal Dr.
San Diego,  CA  92127
Correspondent Contact CAROL PATTERSON
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received08/25/1998
Decision Date 02/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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