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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 K012848
Device Name WINNER CM4 COMBINATION UNIT
Applicant
RICH-MAR CORP.
P.O. BOX 879
INOLA,  OK  74036
Applicant Contact DAVID RICHARDS
Correspondent
RICH-MAR CORP.
P.O. BOX 879
INOLA,  OK  74036
Correspondent Contact DAVID RICHARDS
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
IPF   LIH  
Date Received08/23/2001
Decision Date 10/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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