Cardiovascular · 510(k) · 2023
FaceHeart Vitals Software Development Kit (FH vitals SDK)
FaceHeart Corp.. Cleared by FDA on 1 September 2023 under submission K223622, product code QME (software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate). What FDA's record says, in FDA's words.
Device record · K223622
- Device. FaceHeart Vitals Software Development Kit (FH vitals SDK)DEVICE
- Company. FaceHeart Corp. (KY)COMPANY
- Decision. 1 September 2023, 510(k), substantially equivalent (traditional review); received 5 December 2022DECISION
- Panel. CardiovascularPANEL
- Product code. QME, Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory RateCODE
- Regulation. 21 CFR 870.2785, Class IIREG
- Source. FDA database entry · decision document (13 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The FH Vitals SDK is designed to measure the pulse rate based on the given facial video stream. It is intended for non-invasive spot measurements of pulse rate when the subject is still. This SDK is not intended for use in patients with known or suspected heart arrhythmias. While the SDK can be used for general healthcare, it is not designed to treat patients. The pulse rate measurement results provided by the FH Vitals SDK should complement, but not replace, the user's usual professional medical care and/or medication. If abnormalities are detected during the measurement with the FH Vitals SDK, users are advised to consult a medical professional. The FH Vitals SDK is indicated for use in humans 18 years of age or older who do not require critical care or continuous vital signs monitoring. This software should not be the primary or sole method for assessing an individual's health.
The product code's definition, from FDA's classification record. The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QME. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QME, in Cardiovascular, or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
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