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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 K022405
Device Name MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC
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 Received07/16/2002
Decision Date 08/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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