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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 K833251
Device Name MODEL MK II TENS
Applicant
EUROPEAN ELECTRONIC SYSTEMS, LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
EUROPEAN ELECTRONIC SYSTEMS, LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/23/1983
Decision Date 03/05/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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