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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 K021763
Device Name RS2MI MUSCLE STIMULATOR FAMILY
Applicant
Rs Medical
14401 SE First St.
Vancouver,  WA  98684
Applicant Contact MICHAEL B MCGRAW
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
LIH  
Date Received05/29/2002
Decision Date 06/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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