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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mattress, air flotation, alternating pressure
Regulation Description Alternating pressure air flotation mattress.
Product CodeFNM
Regulation Number 880.5550
Device Class 2


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIO SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GAYMAR INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 8
LUMEX
  SUBSTANTIALLY EQUIVALENT 3
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
PLEXUS BIOMEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
SKYTRON
  SUBSTANTIALLY EQUIVALENT 1
SPAN-AMERICA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 8
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TALLEY GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 1
WHEELCHAIRS OF KANSAS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 26
Decrease in pressure 21
Burn of device or device component 12
No Information 12
Use of Device Issue 11
Improper or incorrect procedure or method 9
Entrapment of device or device component 8
Inflation issue 7
Electrical shorting 6
Air leak 6
Product quality issue 5
Deflation issue 5
Not Applicable 5
Spark 3
Device operates differently than expected 3
Human-Device Interface Issue 3
Patient-device incompatibility 2
Burst 2
Fire 2
Device inoperable 2
Defective component 2
Not audible alarm 2
Smoking 2
Electrical issue 2
Replace 2
Misassembled by Users 2
Loss of power 2
Detachment of device component 2
Device maintenance issue 2
Normal 2
Peeled 2
Fitting problem 2
Component falling 2
Deflation, cause unknown 2
Device alarm system issue 2
Overheating of device or device component 2
Other (for use when an appropriate device code cannot be identified) 2
Break 2
Improper flow or infusion 2
Temperature issue 1
Mechanical issue 1
Inaccurate delivery 1
Cut in material 1
Detachment of device or device component 1
Disconnection 1
Device damaged prior to use 1
Malfunction 1
Manufacturing or shipping issue associated with device 1
Device-device incompatibility 1
Dislodged 1
Foreign material present in device 1
Pressure issue 1
Unintended movement 1
Material separation 1
Inadequate training 1
Device Issue 1
Device handling issue 1
Component incompatible 1
Use of Incorrect Control Settings 1
Pressure, insufficient 1
Unknown (for use when the device problem is not known) 1
Overfill 1
Tipover 1
Therapeutic or diagnostic output failure 1
Material integrity issue 1
Total Device Problems 214

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 0 1 1 0 0 0 1 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Encompass Therapeutic Support Systems dba BG North America II Mar-31-2010
2 Hill-Rom Manufacturing, Inc. II Jan-07-2009
3 SCM True Air Technologies LLC II May-19-2014
4 Stryker Medical Division of Stryker Corporation II Mar-08-2016

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