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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 K881114
Device Name EMPI MODEL 989, TENS
Applicant
Empi
1275 Grey Fox Rd.
Arden Hills,  MN  55112
Applicant Contact E MATHIESEN
Correspondent
Empi
1275 Grey Fox Rd.
Arden Hills,  MN  55112
Correspondent Contact E MATHIESEN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/15/1988
Decision Date 04/15/1988
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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