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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device blood pressure cuff
Regulation Description Blood pressure cuff.
Definition A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve(cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
Product CodeDXQ
Regulation Number 870.1120
Device Class 2


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 5
ADVANTAGE MEDICAL CABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARDICARE COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAREMATE MEDICAL DEVICE CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
CAS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  1
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ETHOX INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 5
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 3
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KOVEN TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
M-PACT
  SUBSTANTIALLY EQUIVALENT 1
NIHON SEIMITSU SOKKI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SUNTECH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
TRIMLINE MEDICAL PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 2
TYTAN MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
UNIMED
  SUBSTANTIALLY EQUIVALENT 2
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 3
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 4
WENZHOU KINDCARE IMPORT & EXPORT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WENZHOU LONGWAN MEDICAL INSTRUMENT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
YA HORNG ELECTRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZEFON INTL.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Material separation 20
Unraveled material 8
No code available 6
Flaked 6
Difficult to remove 4
Break 3
Occlusion within device 2
Split 2
Buckled material 1
Device operates differently than expected 1
Material integrity issue 1
Torn material 1
No Information 1
Peeled 1
Material fragmentation 1
Material frayed 1
Stretched 1
Total Device Problems 60

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

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Jun-22-2011

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