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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 K030254
Device Name INTERFERENTIAL STIMULATOR, MODEL RTM1000
Applicant
Ryan Telemedicine
1011 Brioso Dr.
Costa Mesa,  CA  92627
Applicant Contact JIM KLETT
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact JOHN SO
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
LIH  
Date Received01/24/2003
Decision Date 02/26/2003
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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