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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 K002297
Device Name YORAMED, MODEL T-202
Applicant
UNITED YORAM DISTRIBUTORS, INC.
602 DEGRAW ST.
BROOKLYN,  NY  11217
Applicant Contact MORRIS MIZRAHI
Correspondent
UNITED YORAM DISTRIBUTORS, INC.
602 DEGRAW ST.
BROOKLYN,  NY  11217
Correspondent Contact MORRIS MIZRAHI
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received07/28/2000
Decision Date 03/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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