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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 K120972
Device Name FLEXITOUCH SYSTEM
Applicant
Tactile Systems Technology, Inc.
1331 Tyler St. NE, Suite 200
Minneapolis,  MN  55413
Applicant Contact PHILLIP ROSE
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/02/2012
Decision Date 04/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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