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510(k) Data Aggregation

    K Number
    K043604
    Device Name
    LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE
    Manufacturer
    VIVOMETRICS, INC.
    Date Cleared
    2005-04-29

    (121 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIVOMETRICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LifeShirt Real-Time is intended for use during daily activities of living and sleep, for the purpose of recording physiological data for later analysis by a physician. Respiration, ECG, pulse oximetry, blood pressure, temperature, and body position data may be collected. The system is intended to provide analysis of breathing patterns as an aid in classifying apneas as well as displaying heart rate changes from electrocardiographic waveforms in the wake and sleeping states as well as activities of daily living. The LifeShirt Real-Time is indicated for reuse by multiple adult patients in applications that may include pharmaceutical studies in which respiratory information is a useful indicator, or the general healthcare market where patients may be monitored at home and the data provided to their physicians as an aid to diagnosis and treatment.
    Device Description
    The LifeShirt Real-Time consists of the following components: the LifeShirt garment, LifeShirt Recorder/Transmitter, a wireless flash card, a data Flash Card, VivoMonitor™ real-time software and VivoLogic® analysis and reporting software. A cleared pulse oximeter, blood pressure cuff, and a temperature sensor are optional accessories provided for use with the device.
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    K Number
    K031550
    Device Name
    REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE
    Manufacturer
    VIVOMETRICS, INC.
    Date Cleared
    2003-07-29

    (74 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIVOMETRICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reusable Multiple-Patient LifeShirt is intended for use during daily activities of living and sleep, for the purpose of recording physiological data for later analysis by a physician. Respiration, ECG, pulse oximetry, blood pressure, and body position data may be collected. The system is intended to provide analysis of breathing patterns as an aid in classifying apneas as well as displaying heart rate changes from electrocardiographic waveforms in the wake and sleeping states as well as activities of daily living. The Reusable Multiple-Patient LifeShirt is indicated for reuse by multiple adult patients in applications that may include pharmaceutical studies in which respiratory information is a useful indicator, or the general healthcare market where patients may be monitored at home and the data provided to their physicians as an aid to diagnosis and treatment.
    Device Description
    The Reusable Multiple-Patient LifeShirt consists of the following components: 1. LifeShirt data acquisition system including the vest with inductive plethysmograph sensors, ECG sensors, a data cable and a connected Handspring Visor® device with software for data collection and storage onto a flash memory card; 2. LifeShirt data transfer software to transmit the data from the user's personal computer to the VivoMetrics Data Center; 3. VivoMetrics Data Center, a database operated by VivoMetrics personnel which stores and provides an audit trail for collected data; and 4. VivoLogic data analysis software for viewing and analyzing patient data.
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    K Number
    K011903
    Device Name
    LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE
    Manufacturer
    VIVOMETRICS, INC.
    Date Cleared
    2002-04-12

    (298 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIVOMETRICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Life Shirt system is intended for use by one adult during daily activities of The Life Shirt System is michaea cerading physiological data for later analysis by a physician. Respiration, ECG, pulse oximetry, blood pressure, and body position a physician. The system is intended to provide analysis of breathing data may be conected. Thic tyot appeas as well as displaying heart rate changes patterns as an all in claboring aparis the wake and sleeping states as well as trom electrocardidographic wavelorms in all was were aceutical studies in which acuvities of daily fiving. Trippiesul indicator, or the general healthcare market respiratory information is a userel manue and the data provided to their physicians as an aid to diagnosis and treatment.
    Device Description
    The LifeShirt is a noninvasive ambulatory monitoring device that continuously monitors and stores respiration and ECG onto a CompactFlash™ memory card within a portable battery powered Handspring Visor® worn on a belt or within a pocket. The patient may be located at home or in an alternate care setting. The monitored subject can enter symptoms, activities, and medications into the Handspring Visor® that becomes part of the digital data stream. An optional NONIN pulse oximeter and Critikon noninvasive blood pressure monitor can be connected into the Visor for recordings during sleep or defined activities. The purpose of this system is to collect and store cardiac, respiratory, and blood pressure data as well as body position, various types of activities annotated with symptoms and a medication diary for subsequent analysis and archival at a data center utilizing the VivoLogic 1.0 software program. Data is transferred to the data center generally after the end of a patient data recording session.
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