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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K981643
Device Name RTM DVT PROSOFT CUFF MODEL NUMBER PS100
Applicant
R.T. Medical Services, Inc.
730 W. Portage Trl. Extension
Akron,  OH  44313
Applicant Contact KAREN L DIEHL
Correspondent
R.T. Medical Services, Inc.
730 W. Portage Trl. Extension
Akron,  OH  44313
Correspondent Contact KAREN L DIEHL
Regulation Number870.5800
Classification Product Code
JOW  
Date Received05/08/1998
Decision Date 12/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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