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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 K870168
Device Name EMPI LOGIX MODEL 712 NMS, TENS
Applicant
Empi
261 S. Commerce Cir.
Minneapolis,  MN  55432
Applicant Contact MIRIAM J GOLDBERG
Correspondent
Empi
261 S. Commerce Cir.
Minneapolis,  MN  55432
Correspondent Contact MIRIAM J GOLDBERG
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received01/14/1987
Decision Date 04/01/1987
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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