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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
  1.  K800231  ABCO/GRANT ALTERNATING PRESSURE PAD & UT
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
Air leak 6
Electrical shorting 6
Not Applicable 5
Deflation issue 5
Product quality issue 5
Device operates differently than expected 3
Human-Device Interface Issue 3
Spark 3
Patient-device incompatibility 2
Smoking 2
Fitting problem 2
Other (for use when an appropriate device code cannot be identified) 2
Improper flow or infusion 2
Device inoperable 2
Misassembled by Users 2
Replace 2
Normal 2
Overheating of device or device component 2
Peeled 2
Loss of power 2
Defective component 2
Deflation, cause unknown 2
Electrical issue 2
Device maintenance issue 2
Fire 2
Device alarm system issue 2
Not audible alarm 2
Break 2
Burst 2
Detachment of device component 2
Component falling 2
Component incompatible 1
Use of Incorrect Control Settings 1
Mechanical issue 1
Disconnection 1
Dislodged 1
Inaccurate delivery 1
Device Issue 1
Pressure, insufficient 1
Overfill 1
Malfunction 1
Cut in material 1
Tipover 1
Material separation 1
Device handling issue 1
Pressure issue 1
Temperature issue 1
Therapeutic or diagnostic output failure 1
Unintended movement 1
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Device-device incompatibility 1
Foreign material present in device 1
Unknown (for use when the device problem is not known) 1
Device damaged prior to use 1
Inadequate training 1
Detachment of device or device component 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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