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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 K982410
Device Name SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE
Applicant
REHABILICARE, INC.
1811 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112
Applicant Contact EDWARD F VALDEZ
Correspondent
REHABILICARE, INC.
1811 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112
Correspondent Contact EDWARD F VALDEZ
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received07/13/1998
Decision Date 11/06/1998
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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