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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 K854476
Device Name KALMATE MODEL 3A
Applicant
Medical Technology Systems, Inc.
C/O Companion Products Int'L
6985 Via Del Oro
San Jose,  CA  95119
Applicant Contact ROBERT LANGSTROTH
Correspondent
Medical Technology Systems, Inc.
C/O Companion Products Int'L
6985 Via Del Oro
San Jose,  CA  95119
Correspondent Contact ROBERT LANGSTROTH
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/07/1985
Decision Date 02/27/1986
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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