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510(k) Data Aggregation

    K Number
    K221361
    Device Name
    circul™ pro Ring
    Manufacturer
    BodiMetrics, LLC
    Date Cleared
    2023-08-29

    (475 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    BodiMetrics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The circul™ pro Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot-check and/ or continuous data collection of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through the index finger in adult patients. It can be used in home environments for up to twelve hours in non-motion and well perfused conditions. It is not intended for single-use and out-of-hospital transport use and does not have alarms.
    Device Description
    The circul™ pro Ring is a small, wearable, non-invasive, wireless device that the user wears on one finger. The ring features an adjustable fit (by means of multiple ring sizes (S, L, XL) and a spring fit) for comfort and can be worn on any finger on either hand. The circul pro Ring relies on an optical sensor to detect oxygen saturation (SpO2) and pulse rate (PR). The sensor uses two wavelengths of LEDs: Red: with a wavelength of 660 nm ± 10 nm, Infrared: with a wavelength of 940 nm ± 20 nm. The blood oxygen percentage is calculated based on measuring the passage of the two wavelengths of light (with different absorption rates) through the body, also known as Reflective Oximetry. The integrated sensor technology works to determine the blood oxygen content by determining the light absorption when the skin is illuminated. The circul pro Ring features a spring mechanism, and the elastic structure of the embedded sensor and inner arch of the ring are ergonomically shaped to offer a snug fit, preventing it from slipping off the finger, stabilizing the sensor on the 'belly' of the finger, and minimizing twisting of the ring on the wearer's finger. This also helps to reduce the likelihood of poor SpO2 readings in patients with darker skin pigments.
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