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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Depth
510(k) Number K946018
Device Name TENS-IT, FITTRONIC II, (MORE LATER)
Applicant
Ems, Inc.
P.O. Drawer 179
Pen Valley,  CA  95946
Applicant Contact THOMAS V DAIGLE
Correspondent
Ems, Inc.
P.O. Drawer 179
Pen Valley,  CA  95946
Correspondent Contact THOMAS V DAIGLE
Regulation Number882.1330
Classification Product Code
GZL  
Date Received12/09/1994
Decision Date 11/09/1995
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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