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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K003260
Device Name VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460
Applicant
Metron Medical Australia, Pty, Ltd.
57 Aster Ave.
Carrum Downs,  AU 3201
Applicant Contact ROB HOPKINS
Correspondent
Metron Medical Australia, Pty, Ltd.
57 Aster Ave.
Carrum Downs,  AU 3201
Correspondent Contact ROB HOPKINS
Regulation Number890.5850
Classification Product Code
IPF  
Date Received10/18/2000
Decision Date 02/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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