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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 K963125
Device Name M AND R REUSABLE ELECTRODES (MULTIPLE)
Applicant
M & R MFG., INC.
11967 UPPER FREDERICKTOWN
AMITY RD.
FREDERICKTOWN,  OH  43019
Applicant Contact RUSSELL A LATIMER
Correspondent
M & R MFG., INC.
11967 UPPER FREDERICKTOWN
AMITY RD.
FREDERICKTOWN,  OH  43019
Correspondent Contact RUSSELL A LATIMER
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received08/12/1996
Decision Date 02/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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