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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 9
Improper or incorrect procedure or method 7
Entrapment of device or device component 6
Air leak 4
Product quality issue 4
Burn of device or device component 3
No Information 3
Not Applicable 2
Spark 2
Other (for use when an appropriate device code cannot be identified) 2
Fire 2
Replace 2
Deflation, cause unknown 2
Normal 2
Overheating of device or device component 2
Decrease in pressure 1
Dislodged 1
Electrical issue 1
Smoking 1
Inadequate training 1
Use of Device Issue 1
Device maintenance issue 1
Mechanical issue 1
Detachment of device component 1
Component incompatible 1
Unknown (for use when the device problem is not known) 1
Device damaged prior to use 1
Inaccurate delivery 1
Device Issue 1
Pressure, insufficient 1
Overfill 1
Malfunction 1
Cut in material 1
Device operates differently than expected 1
Device-device incompatibility 1
Foreign material present in device 1
Temperature issue 1
Total Device Problems 74

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 1 1 0 0 0
Class III 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

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