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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sleeve, limb, compressible
Regulation Description Compressible limb sleeve.
Product CodeJOW
Regulation Number 870.5800
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
AIRCAST, INC.
  SUBSTANTIALLY EQUIVALENT 7
ALLIANCE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 6
ASCENT HEALTHCARE SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
AUGUSTINE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIO COMPRESSION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 7
C-BOOT LTD.
  SUBSTANTIALLY EQUIVALENT 2
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 2
COMPRESSION TECHNOLOGIES UNLIMITED, INC.
  SUBSTANTIALLY EQUIVALENT 1
COMPRESSION THERAPY CONCEPTS
  SUBSTANTIALLY EQUIVALENT 3
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 4
CURRIE MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
DIDECO
  SUBSTANTIALLY EQUIVALENT 1
DJ ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 3
DOCTORS ORDERS
  SUBSTANTIALLY EQUIVALENT 1
GAYMAR INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
HUNTLEIGH HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 5
HYGIA HEALTH SERVICES, INC.
  SUBSTANTIALLY EQUIVALENT 9
KENDALL
  SUBSTANTIALLY EQUIVALENT 7
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
  SUBSTANTIALLY EQUIVALENT 4
MEGO AFEK
  SUBSTANTIALLY EQUIVALENT 4
MICROTEK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
RENU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
SENTECH MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERILMED
  SUBSTANTIALLY EQUIVALENT 2
TACTILE SYSTEMS TECHNOLOGY INC
  SUBSTANTIALLY EQUIVALENT 4
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
UNIVERSITY OF UTAH HOSPITALS AND CLINICS
  SUBSTANTIALLY EQUIVALENT 2
VANGUARD MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Grounding malfunction 76
No Known Device Problem 73
Unknown (for use when the device problem is not known) 68
Burn of device or device component 35
Break 33
Electrical issue 24
Use of Device Issue 20
Scratched material 18
Spark 17
Other (for use when an appropriate device code cannot be identified) 14
Smoking 10
Arcing 8
Leak 7
No Information 7
Cut in material 7
Fire 6
Device operates differently than expected 5
Device displays error message 5
Melted 4
Improper or incorrect procedure or method 4
Electromagnetic compatibility issue 3
Size incorrect for patient 3
Electrical shorting 2
User used incorrect product for intended use 2
Charred 2
Device alarm system issue 2
No code available 2
Inflation issue 2
Drift 1
Fracture 1
Device stops intermittently 1
High sensing threshold 1
Material integrity issue 1
Capturing issue 1
Degraded 1
No display or display failure 1
Material frayed 1
Component falling 1
Disconnection 1
Kinked 1
Device damaged prior to use 1
Device unsafe to use in environment 1
Material Distortion 1
Difficult to position 1
Failure to run on AC/DC 1
Split 1
Detachment of device or device component 1
Naturally worn 1
Output issue 1
Torn material 1
Inaccurate delivery 1
Air leak 1
Failure to power-up 1
Misapplication 1
Pressure issue 1
Total Device Problems 486

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 1 1 1 2 3 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Albahealth LLC II Nov-14-2011
2 Arjo, Inc. dba ArjoHuntleigh II Dec-27-2012
3 Ascent Healthcare Solutions, Inc. II Sep-19-2008
4 Covidien LP II Oct-01-2010
5 DJO, LLC II Jul-03-2013
6 Medical Compression Systems II Jan-11-2012
7 Sterilmed Inc II Jan-13-2009
8 Stryker Sustainability Solutions II Feb-20-2013
9 Surgical Instrument Service And Savings, Inc. II Jul-01-2013

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