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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device transmitters and receivers, physiological signal, radiofrequency
Regulation Description Radiofrequency physiological signal transmitter and receiver.
Product CodeDRG
Regulation Number 870.2910
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
AFRAME DIGITAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOCOMFORT DIAGNOSTICS GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
BRAEMAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOCOM LLC
  SUBSTANTIALLY EQUIVALENT 1
CAREMATIX INC.
  SUBSTANTIALLY EQUIVALENT 3
CERNER CORP.
  SUBSTANTIALLY EQUIVALENT 1
CONFIDANT INC.
  SUBSTANTIALLY EQUIVALENT 3
CRITICARE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL A.C.A.L.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
HEALTH HERO NETWORK, INC.
  SUBSTANTIALLY EQUIVALENT 4
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 2
HONEYWELL HOMMED, LLC
  SUBSTANTIALLY EQUIVALENT 5
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEL CORP.
  SUBSTANTIALLY EQUIVALENT 3
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 1
INTOUCH TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 2
MEDAPPS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDIC4ALL (ISRAEL) LTD.
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICOMP
  SUBSTANTIALLY EQUIVALENT 2
MORTARA
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 6
NOVAMETRIX
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RTX HEALTHCARE A/S
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device operates differently than expected 58
Device inoperable 39
Charred 14
Burn of device or device component 12
Power Conditioning Issue 11
Overheating of device or device component 10
Failure to fire 7
Communication or transmission issue 7
No Known Device Problem 6
Temperature issue 6
Device stops intermittently 6
Wireless communication issue 4
Battery issue 3
Burst 3
Melted 2
Fire 2
Radiofrequency interference (RFI) 2
Device displays error message 1
Inappropriate shock 1
Incorrect measurement 1
Failure to capture 1
Battery failure 1
Break 1
Intermittent continuity 1
Application interface becomes non-functional or program exits abnormally 1
No display or display failure 1
Device markings issue 1
Output issue 1
Power source issue 1
Material integrity issue 1
Total Device Problems 205

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 1 1 0 0 0 0 2 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 BRAEMAR, INC. II Jul-02-2013
2 BRAEMAR, INC. II Jul-02-2013
3 GMP Companies/Lifesync Corporation II Feb-27-2007
4 Lifesync Corporation II Sep-16-2008
5 Philips Visicu II Apr-22-2016

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