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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 K872574
Device Name TENSAGAIN
Applicant
Ferris Mfg. Corp.
16 W. 300 83rd St.
Burr Ridge,  IL  60527
Applicant Contact LALAGOS
Correspondent
Ferris Mfg. Corp.
16 W. 300 83rd St.
Burr Ridge,  IL  60527
Correspondent Contact LALAGOS
Regulation Number882.1320
Classification Product Code
GXY  
Date Received06/30/1987
Decision Date 07/23/1987
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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