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philips heartstart frx defibrillator model 861304
Philips Medical Systems
Summary: The Philips HeartStart FRx Defibrillator is a portable device used to treat sudden cardiac arrest. It is designed for use by both trained responders and laypersons in emergency situations.
FDA Clearance Information
Pathway
510K
Number
K050004 ↗
Decision Date
February 25, 2005
Product Code
MKJ
Device Class
Class 3
Evidence
419 studies
The Philips HeartStart FRx Defibrillator was cleared through the FDA 510k pathway on February 25, 2005. It is manufactured by Philips Medical Systems and classified as a Class III device.
What It Is
The Philips HeartStart FRx Defibrillator is an automated external defibrillator (AED) designed to deliver a therapeutic dose of electrical energy to the heart in cases of life-threatening cardiac arrhythmias. It is user-friendly, with voice prompts and visual icons to guide the user through the defibrillation process. The device is rugged and reliable, suitable for use in various environments.
Clinical Applications
This device is commonly used in pre-hospital settings, such as ambulances, and in public places like airports and sports venues. It is also found in hospitals and clinics as a part of emergency response equipment. The HeartStart FRx is used by emergency medical technicians, first responders, and even laypersons trained in CPR and AED use, to treat patients experiencing sudden cardiac arrest.
Indications for Use
The FDA indications for the Philips HeartStart FRx Defibrillator include use in patients experiencing sudden cardiac arrest, a condition where the heart suddenly stops beating effectively. It is intended for use on both adults and children with appropriate pediatric pads.
Practical Considerations
The HeartStart FRx is compatible with standard adult and pediatric electrode pads. It features a robust design to withstand harsh conditions and is easy to maintain with long-life batteries and pads. It is important to ensure the device is regularly checked and maintained for readiness.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Philips HeartStart FRx Defibrillator used for?
It is used to deliver a controlled electric shock to the heart of a person experiencing sudden cardiac arrest to restore a normal heart rhythm.
What specialties typically use this device?
Emergency medical services, cardiology, and any setting where first responders are trained to handle cardiac emergencies.
What are the FDA-cleared indications?
The device is indicated for use in treating sudden cardiac arrest in adults and children, with appropriate accessories.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.