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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 K896825
Device Name TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR
Applicant
Infrasonics Corp.
3944b NE 5th Ave.
Oakland Park,  FL  33334
Applicant Contact MARVIN P CURRY
Correspondent
Infrasonics Corp.
3944b NE 5th Ave.
Oakland Park,  FL  33334
Correspondent Contact MARVIN P CURRY
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received12/05/1989
Decision Date 11/16/1990
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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