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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 K011017
Device Name PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT
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 Received04/04/2001
Decision Date 09/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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