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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 K843637
Device Name HEALTH PULSE FA-222 TRANSCUTANEOUS ELEC. NERVE STI
Applicant
Therapeutic Equipment Corp.
60 Page Rd.
Clifton,  NJ  07012
Applicant Contact ALAN P SCHWARTZ
Correspondent
Therapeutic Equipment Corp.
60 Page Rd.
Clifton,  NJ  07012
Correspondent Contact ALAN P SCHWARTZ
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/17/1984
Decision Date 11/29/1984
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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