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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 K874469
Device Name TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)
Applicant
AXELGAARD MFG. CO., LTD.
104 WEST ELDER ST.
FALLBROOK,  CA  92028
Applicant Contact WALTER A HACKLER
Correspondent
AXELGAARD MFG. CO., LTD.
104 WEST ELDER ST.
FALLBROOK,  CA  92028
Correspondent Contact WALTER A HACKLER
Regulation Number882.1320
Classification Product Code
GXY  
Date Received11/02/1987
Decision Date 01/28/1988
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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