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510(k) Data Aggregation

    K Number
    K123539
    Device Name
    STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK
    Manufacturer
    STAYHEALTHY, INC.
    Date Cleared
    2013-04-22

    (157 days)

    Product Code
    DXN, HIT, MNW
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    STAYHEALTHY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stayhealthy SH650 is intended to be used by the general public so that the user can measure his/her own blood pressure, heart rate, percent lean body mass, percent body fat, percent total body water, body weight, and if the user may have color blindness. It is not a diagnostic device and only furnishes data so that users can consult their personal physicians or other healthcare professional. The user can also choose to print the data or send the data to a personal physician or a healthcare professional.
    Device Description
    Not Found
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    K Number
    K101807
    Device Name
    STAYHEALTHY BODY COMPOSITION MONITOR-BCM
    Manufacturer
    STAYHEALTHY, INC.
    Date Cleared
    2011-01-26

    (212 days)

    Product Code
    MNW
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    STAYHEALTHY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BCM is used as body fat analyzer that estimate the percent body fat (%BF), percent lean body mass(%LBM) and percent total body water (TBW%) with the use of BIA (bioelectrical impedance analysis). The SAM or Stayhealthy Activity Monitor [ a triaxial accelerometer and 3axis, gyroscope equipped calorie tracker- (CT2)], is a device that is sold as companion device with the BCM and is used to track the number of calories used by the client. The device is intended for use by healthy subjects ages 8-92.
    Device Description
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    K Number
    K052522
    Device Name
    STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2
    Manufacturer
    STAYHEALTHY, INC.
    Date Cleared
    2005-12-13

    (90 days)

    Product Code
    MNW
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    STAYHEALTHY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stayhealthy BC1 and the Stayhealthy/Fitness Expert BC2 devices are used solely to estimate the body fat and lean muscle components of the body using bioelectrical impedance technology. The Stayhealthy Calorie tracker (CT1) and the Stayhealthy/Fitness Expert Calorie Tracker (CT2) are companion devices and are used solely to determine the calories used by a client when worn for a given period of time. The BC1 and BC2 can output, via computer driven software the percent body fat of a person. The lean body mass can also be displayed. The devices are intended for use by both men and women who are 18 and older. The CT1 and the CT2 the companion devices can output, via computer driven software the number calories used by a person. The calories used can also be displayed. The BC1, BC2, CT1 and CT2 are not intended to be used to diagnose any known disease.
    Device Description
    The Stayhealthy BC1 and Stayhealthy/ Fitness expert BC2, Body Composition Analyzer is a computer-operated and web enabled body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat percent and lean body mass percent. Both devices are about 10 inches across. The BC1 has an oval shape and is about 3 inches thick. The BC2 has an almost square shape with rounded corners. Both devices are made of slate grey plastics with polished metal inserts that are held by the hands to emit and receive signals to and from the body. The BC1 has an RS232 output socket and the BC2 has a USB output socket. Both devices have a dock where the calorie tracker is docked to upload its data. The CT1 and CT2 are both about 2 by 3 inches and made of slate gray plastics with a single display window and a docking port. They can be attached to clothes on the body via a clip on the back.
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