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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 K864735
Device Name A-TENS - MODEL AI-87
Original Applicant
4886 paseo de vega
irvine,  CA  92715
Original Contact joan fong
Regulation Number882.5890
Classification Product Code
Date Received12/04/1986
Decision Date 02/20/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No