FloPatch FP120
Flosonics MedicalThe FloPatch FP120 is a non-invasive cardiovascular blood flowmeter intended for use by medical professionals in hospitals and clinical settings. It utilizes continuous wave Doppler ultrasound to assess blood flow in peripheral vasculature. The device wirelessly transmits Doppler signals to a mobile application that displays blood flow measurements such as Max Velocity, Velocity Time Integral (VTI), and Corrected Flow Time, helping clinicians noninvasively monitor vascular health.
Intended Use
The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in peripheral vasculature with continuous wave ultrasound mode. It is intended for use by medical professionals in hospital and professional environments on adults, prescription use only.
Technology
The device consists of an ultrasonic transducer and a signal processing unit mounted on an adhesive strap. It transmits continuous wave ultrasound to peripheral vessels, receives Doppler-shifted signals reflected by moving blood cells, and wirelessly transmits data to a mobile medical application for processing and display of flow parameters.
Performance
Performance testing verified the device meets requirements for acoustic output, ultrasound safety and performance, electrical safety, EMC, ingress protection (IP67), material and shelf life, usability, hardware, and software including flow accuracy and algorithm validation. Biocompatibility tests and simulated use cycle testing were also passed, demonstrating safety and effectiveness for its indications.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/11/2025
2 months - 2
FDA Approval
6/20/2025
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