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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 K111748
Device Name RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A
Applicant
Joy Long
7750 Zionsville Rd.
# 850
Indianapolis,  IN  46268
Applicant Contact JOY LONG
Correspondent
Joy Long
7750 Zionsville Rd.
# 850
Indianapolis,  IN  46268
Correspondent Contact JOY LONG
Regulation Number870.5800
Classification Product Code
JOW  
Date Received06/22/2011
Decision Date 11/23/2011
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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