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510(k) Data Aggregation

    K Number
    K231288
    Device Name
    Vyvo
    Date Cleared
    2024-03-04

    (305 days)

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

    Vyvo Technology Corp.(VT)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VYVO Life Watch is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. It is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use.
    Device Description
    The Life Watch, Model WL is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate (PR). The expected measuring location of the device is the finger, which actively presses onto the sensor on the side of the watch for measurement. The Life Watch is a watch-like device with a reflectance pulse oximetry sensor located at the side of the reflectance pulse oximetry sensor includes two light emitting diodes (LEDs) of red wavelength (660 nm) and infrared wavelength (940 nm), and one photodiode light detector placed next to each other. Light beams are emitted from LEDs through the skin to the arteriolar bed of the tissue. Changes in light absorption during the pulsing cycle are measured by the photodiode light detector as scattered lights are reflected back from the pulsating arteriolar bed. The functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate are measured by the well-established non-invasive pulse oximetry technology where the red and infrared light is absorbed in different amounts depending on the oxygenation of the blood during the arterial pulsing. The maximum optical output power is less than 2 mW. The Life Watch is a single-patient use, non-sterile pulse oximeter. It is available in one configuration as a standalone device with a wrist pulse oximeter and a detachable watchband for wearing the pulse oximeter on the wrist. The Life Watch is a compact and light weight device which consists of a reflectance pulse oximetry sensor, a color graphic OLED display, a lithium ion polymer rechargeable battery, an analog and digital unit, a microprocessor and an operating software. The functions of the life watch include the following: (1) Measurement and display of the functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate; (2) Spot-checking of specific physiological parameters of adult patients; (3) Easy to read OLED graphic display; (4) Peripheral micro-USB connector used as the battery charging base; (5) Built-in rechargeable lithium ion polymer battery (3.8V, 250mAh) (6) Low battery power indicator in OLED graphic display. The device consists of the watch case, band, charging case, USB cable. The proposed device is not used for life-supporting or life-sustaining, and not for implant. The device does not contain drug or biological products.
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