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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 K131387
Device Name WRIGHT GRADIENT 52 - TORSO
Applicant
Wright Therapy Products, Inc.
103-B International Dr.
Oakdale,  PA  15071
Applicant Contact CAROL WRIGHT
Correspondent
Wright Therapy Products, Inc.
103-B International Dr.
Oakdale,  PA  15071
Correspondent Contact CAROL WRIGHT
Regulation Number870.5800
Classification Product Code
JOW  
Date Received05/14/2013
Decision Date 11/20/2013
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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