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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 K923970
Device Name INTEGRITY 2
Applicant
Medrotech Corp.
3748 Prospect Ave., Suite 3
Riviera Beach,  FL  33404
Applicant Contact SAMUEL P ROSENFELD
Correspondent
Medrotech Corp.
3748 Prospect Ave., Suite 3
Riviera Beach,  FL  33404
Correspondent Contact SAMUEL P ROSENFELD
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received08/06/1992
Decision Date 05/18/1993
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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