• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 1
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 38
Charred 14
Burn of device or device component 12
Power Conditioning Issue 11
Overheating of device or device component 9
Failure to fire 7
Communication or transmission issue 7
No Known Device Problem 6
Device stops intermittently 6
Temperature issue 5
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 202

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 1 1 0 0 0 0 2 0 0 1
Class III 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

-
-