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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K864032
Device Name EM TENS WINDOW ELECTRODES
Applicant
Electromed Intl., Ltd.
34 Bear Hill Rd.
Waltham,  MA  02154
Applicant Contact MEGAN J MACAULEY
Correspondent
Electromed Intl., Ltd.
34 Bear Hill Rd.
Waltham,  MA  02154
Correspondent Contact MEGAN J MACAULEY
Regulation Number882.1320
Classification Product Code
GXY  
Date Received10/15/1986
Decision Date 12/22/1986
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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