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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 K031884
Device Name INTERFERENTIAL STIMULATOR, MODEL NETWAVE
Applicant
Ryan Telemedicine
1011 Brioso Dr., Suite 102
Costa Mesa,  CA  92660
Applicant Contact JIM KLETT
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Regulation Number890.5850
Classification Product Code
IPF  
Date Received06/18/2003
Decision Date 06/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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