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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Transcutaneous, For Arthritis
510(k) Number K062325
Device Name RS-4I MUSCLE STIMULATOR FAMILY
Applicant
RS MEDICAL
P.O. BOX 3515
REDMOND,  WA  98073
Applicant Contact STEVEN CHERNOFF
Correspondent
RS MEDICAL
P.O. BOX 3515
REDMOND,  WA  98073
Correspondent Contact STEVEN CHERNOFF
Regulation Number882.5890
Classification Product Code
NYN  
Date Received08/09/2006
Decision Date 04/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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