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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K013771
Device Name MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
Applicant
Rich-Mar Corp.
15499 E. 590th Rd.
P.O. Box 879
Inola,  OK  74036
Applicant Contact DAVID RICHARDS
Correspondent
Rich-Mar Corp.
15499 E. 590th Rd.
P.O. Box 879
Inola,  OK  74036
Correspondent Contact DAVID RICHARDS
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZJ   IMG   IMI   LIH  
Date Received11/13/2001
Decision Date 01/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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