đź“‹ FDA Reference
philips heartstart fr3 defibrillator
Philips Medical Systems
Summary: The Philips HeartStart FR3 Defibrillator is an advanced automated external defibrillator (AED) used for treating sudden cardiac arrest. It is primarily used by emergency medical personnel and trained first responders.
FDA Clearance Information
Pathway
PMA
Number
P160028 ↗
Decision Date
January 11, 2021
Product Code
MKJ
Device Class
Class 3
Evidence
419 studies
The Philips HeartStart FR3 Defibrillator received FDA clearance via PMA P160028 on January 11, 2021. It is manufactured by Philips Medical Systems and classified as a Class 3 medical device.
What It Is
The Philips HeartStart FR3 Defibrillator is a portable, automated external defibrillator designed to deliver electrical shocks to the heart in cases of sudden cardiac arrest. It features advanced technology for quick and effective defibrillation, with a user-friendly interface and voice prompts to guide the user through the process. The device is lightweight and durable, making it suitable for use in various emergency settings.
Clinical Applications
This defibrillator is commonly used in pre-hospital emergency care settings, such as by paramedics and emergency medical technicians (EMTs) in ambulances. It is also used in public spaces, workplaces, and healthcare facilities where rapid response to cardiac emergencies is critical. The device is suitable for adult and pediatric patients experiencing sudden cardiac arrest.
Indications for Use
The FDA clearance includes modifications to the rechargeable battery used in the FR3 Defibrillator, ensuring continued reliability and performance. This device is indicated for use in patients experiencing sudden cardiac arrest, providing life-saving defibrillation when needed.
Practical Considerations
The Philips HeartStart FR3 Defibrillator is compatible with a range of electrode pads and accessories, ensuring versatility in different clinical scenarios. It is important for users to be trained in its operation to maximize effectiveness. Regular maintenance and battery checks are recommended to ensure 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 FR3 Defibrillator used for?
It is used to deliver electrical shocks to the heart in cases of sudden cardiac arrest to restore normal heart rhythm.
What specialties typically use this device?
Emergency medical services, including paramedics and EMTs, as well as trained first responders in various settings.
What are the FDA-cleared indications?
The device is indicated for use in patients experiencing sudden cardiac arrest, with recent battery modifications approved for reliability.
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.