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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 K032652
Device Name RS-4I MUSCLE STIMULATOR FAMILY
Applicant
RS MEDICAL
14401 S.E. FIRST ST.
VANCOUVER,  WA  98684
Applicant Contact MICHAEL B MCGRAW
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
CAMAS,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
LIH  
Date Received08/28/2003
Decision Date 09/12/2003
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
Recalls CDRH Recalls
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