Who is the manufacturer of HealthChek Network Health Station?

Healthchek Network, LLC filed the 510(k) submission for HealthChek Network Health Station (K152107).

What is the FDA product code for HealthChek Network Health Station?

DXN. It is classified under 21 CFR 870.1130 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for HealthChek Network Health Station?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HealthChek Network Health Station?

StayHealthy HealthCENTER Biometric Screening Kiosk (K123539).

Who can help prepare an FDA 510(k) submission like HealthChek Network Health Station?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HealthChek Network Health Station

K152107 · Healthchek Network, LLC · DXN · Apr 12, 2016 · Cardiovascular

Device Facts

Record ID	K152107
Device Name	HealthChek Network Health Station
Applicant	Healthchek Network, LLC
Product Code	DXN · Cardiovascular
Decision Date	Apr 12, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1130
Device Class	Class 2

Intended Use

The HCK - 2000 (health station) is an automated system intended to be used by the general adult public, in public environments, so that the user can measure his/her own health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. It is not a diagnostic device and only furnishes data so that users can consult their personal physicians or other healthcare professional. For personal reference purposes, the user can also choose to print or store their data on the HealthChek network's database.

Device Story

HealthChek Network Health Station (HCK-2000) is a public-access kiosk for self-measurement of health parameters. Inputs include user-entered height (for BMI), weight (via load cell in seat), and blood pressure/heart rate (via SunTech Advantage Model 2 NIBP module with kiosk cuff). Device operates in public environments; user interacts via touch screen. Output includes on-screen display and printed results; data can be stored on a remote database via Ethernet. Device is not diagnostic; intended to provide data for consultation with healthcare professionals. Benefits include convenient access to health monitoring for the general public.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (safety) and IEC 80601-2-30 (automated sphygmomanometers) demonstrated. No clinical trials performed due to long-established use of health monitoring kiosks.

Technological Characteristics

Kiosk-based system; Windows 7 OS. NIBP module: SunTech Advantage Model 2 (firmware ct3.39.0) with SunTech Kiosk Cuff. Weight measurement: load cell. Connectivity: Ethernet. Materials: Blood pressure cuff compliant with ISO 10993. Standards: IEC 60601-1, IEC 60601-1-2, IEC 80601-2-30, ISO 14971, HIPAA, RoHS.

Indications for Use

Indicated for general adult public use in public environments to measure blood pressure, heart rate, BMI, and body weight. Not for diagnostic use. Contraindicated for neonatal, pregnant, or pre-eclamptic patients.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

StayHealthy HealthCENTER Biometric Screening Kiosk (K123539)

Related Devices

K123539 — STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK · Stayhealthy, Inc. · Apr 22, 2013
K151127 — higi Station · Higi Sh, LLC · Dec 8, 2015
K172739 — higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) · Higi Sh, LLC · Oct 10, 2017
K063008 — HEALTH CHECK KIOSK · Xperex Corporation · Jun 7, 2007
K101198 — CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K · Computerized Screening, Inc. · Aug 4, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing right. The logo is black and white. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 12, 2016 HealthChek Network, LLC % John Ziobro Principal Consultant SpectraMedEx, LLC 117 W. South Street Oconomowoc. Wisconsin 53066 Re: K152107 Trade/Device Name: Healthchek Network Health Station, Model HCK - 2000 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, FRW Dated: March 3. 2016 Received: March 9, 2016 Dear John Ziobro: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device {1}------------------------------------------------ related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Mitchell Stein for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K152107 Device Name HealthChek Network Health Station, Model HCK - 2000 Indications for Use (Describe) The HCK - 2000 (health station) is an automated system intended to be used by the general adult public, in public environments, so that the user can measure his/her own health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. It is not a diagnostic device and only furnishes data so that users can consult their personal physicians or other healthcare professional. For personal reference purposes, the user can also choose to print or store their data on the HealthChek network's database. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| _ | Prescription Use (Part 21 CFR 801 Subpart D) |X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for HealthChek Network. The logo consists of a blue checkmark inside of a circle on the left. To the right of the checkmark is the word "HealthChek" in gray and blue. Below "HealthChek" is the word "Network" in gray. VOLUME 2 SECTION 3 ### Traditional 510(k) Summary - 1. Summary Date 3/3/2016 | 2. Applicant Name: | HealthChek Network, LLC 135 West Sallier St. Lake Charles, LA 70601 Ph 608-320-636 Establishment Registration Number: Pending | |--------------------|-------------------------------------------------------------------------------------------------------------------------------------------| |--------------------|-------------------------------------------------------------------------------------------------------------------------------------------| 3. Submission Correspondent: On behalf of HealthChek Networks, LLC, the following consultant is assigned the responsibility of submission correspondence: John F. Ziobro, Principal Consultant SpectraMedEx, LLC 3215 Golf Road, #149 Delafield, WI 53018 Ph: 262.719.8922 - 4. Trade Name: HealthChek Network Health Station, Model HCK - 2000 - న్. Common Name: Health Kiosk - Description: Noninvasive blood pressure measurement system (Per FDA classification) 6. The HealthChek Network Health Station, Model HCK - 2000 is a kiosk designed for use by the general adult public in public locations to measure the user's health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. The HealthChek Network Health Station kiosk is not a diagnostic device. It does not introduce any novel modes of operational theory. #### 7. Manufacturing Site: GMI Solutions 10202 North Enterprise Drive Mequon, WI 53092 USA (262) 242-8800 Establishment Registration Number: 2134848 Suggested Classification Regulation, Class & Product Code & Panel (NIBP unit): 8. 21 CFR 870.1130 Class II Product Code: DXN Panel: Cardiovascular - 9. Additional Suggested Classification Regulation, Class & Product Code & Panel (Patient scale): 21 CFR 880.2720 Class I Product Code: FRW Panel: General Hospital & Personal Use #### 10. Reason for Traditional 510(k): New submission | 11. Predicate Device(s): | 510(k) Number: | K123539 | |--------------------------|-----------------|--------------------------------------------------------------------------------------------------------------------| | | Manufacture: | StayHealthy | | | Trade Name: | HealthCENTER Biometric Screening Kiosk | | | Product Code: | DXN (Noninvasive blood pressure measurement system) HIT (Color vision tester) MNW (Impedance plethysmograph) | | | Classification: | DXN: 21 CFR 870.1130 | HealthChek Network Health Station Traditional 510(k) Submission 005 VOL 002 003 Traditional 510(k) Summary - REVISED.docx Confidential Page 002/003-1 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for HealthChek Network. The logo features a blue checkmark inside of a circle on the left side of the image. To the right of the checkmark is the word "HealthChek" in gray and blue lettering, with "Network" in smaller gray lettering below it. VOLUME 2 SECTION 3 HIT: 21 CFR 886.1170 (510(k) Exempt) MNW: 21 CFR 870.2770 (510(k) Exempt) - 12. Compliance to Special Controls / Performance Standards: Compliance to the following recognized consensus standards is declared: ### Quality System Standards. - CFR 21CFR820: Part 820 Quality System Regulations ● - . ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes #### Safety Standards / Testing Compliance: - IEC 60601-1:2005 3rd edition General requirements for basic safety and essential performance - . IEC 60601-1-2:2007 3rd edition Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (with immunity testing to IEC 60601-1-2:2014 4th edition) - . IEC 80601-2-30:2009 Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers #### Design Standards - ISO 14971:2007 Medical devices Application of risk management to medical devices . - . 47CFR Part 15 Federal Communications Commission (FCC) - . 2002/95/EC Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) - . HIPAA Compliant - 13. Indication for Use The HCK - 2000 (health station) is an automated system intended to be used by the general adult public, in public environments, so that the user can measure his/her own health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. It is not a diagnostic device and only furnishes data so that users can consult their personal physicians or other healthcare professional. For personal reference purposes, the user can also choose to print or store their data on the HealthChek network's database. #### 14. Technological Characteristics The hardware and software is very similar to other products on the market and does not differ significantly in any respect. This system is combines the hardware and software platforms of the predicates and as such has it has identical technological characteristics. - 15. Testing Bench Testing was conducted on a unit with all design options (card reader, printer, etc.) per the requirements of IEC 60601-1 as well as the requirements for blood pressure units (per IEC 60101-2-30). Testing shows that the device is in compliance with the cited standards. Because of the long-established use of health monitoring kiosks, no clinical trial was performed. - 16. Comparison to Predicates The main difference between the proposed device and its predicate pertains to the physiological parameters that are measured. Both devices measure blood pressure and heart rate (using the same module supplied by Suntech), and both measure weight. However, the proposed device measures Body Mass Index (BMI) using the measured weight and a height value that the user manually enters. The predicate device instead presents three similar but distinct values, namely the Percent lean body mass, the Percent body fat and the Percent total body water. In addition, the predicate device tests for color blinded and has an option to present hydration. Of all of these parameters, Blood Pressure is regulated as a Class II device subject to 510(k) market clearance and the differences the alternative measured parameters in do not affect the relative safety and/or effectiveness. For additional information see Table 1. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for HealthChek Network. The logo features a blue checkmark symbol on the left, followed by the text "HealthChek" in gray and blue. Below "HealthChek" is the word "Network" in a smaller, lighter gray font. The logo is simple and professional, conveying a sense of trust and reliability. VOLUME 2 SECTION 3 - 17. Conclusions HealthChek believes proposed HealthChek Network Model HCK-2000 and its predicate, the StayHealthCENTER Biometric Screening Kiosk System, are substantially equivalent in their intended use, intended users, intended use environment and indications for use. Furthermore, both systems have the same/equivalent technological characteristics, physical characteristics and safety standards. The main difference that exists between the devices, relating to the measured physiological parameters do not affect the relative safety and/or effectiveness or the intended use/indication for use of the device #### Table 1: Substantial Equivalence Comparison | | HealthChek Network Model HCK - 2000 (Health Station System Under Review) | StayHealthy HealthCENTER Biometric Screening Kiosk (Cleared under K123539) | Substantial Equivalence Comments | |------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | | COMPARISON OF USES/INDICATIONS | | | Intended Use / Indication for Use | The HCK - 2000 (health station) is an automated system intended to be used by the general adult public, in public environments, so that the user can measure his/her own health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. It is not a diagnostic device and only furnishes data so that users can consult their personal physicians or other healthcare professional. For personal reference purposes, the user can also choose to print or store their data on the HealthChek network's database. | The Stayhealthy SH-650 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. | Both devices are for use by the general public to monitor general health parameters. Although the devices measure different parameters, neither device nor any of the measured parameters are used for diagnostic purposes. In addition, the proposed device does not allow the user to transmit their data to a healthcare professional. Instead the data is automatically stored on the HealthChek's database and is made available to the user for their reference. This is a marketing feature and does not affect the safety of the user. Therefore, Substantially Equivalent | | Intended User | General Public | General Public | Both devices have identical intended users. Therefore, Substantially Equivalent | | Intended Use Environment | General Public Environments | From Website: Business, Government, Home, Research, Health Clubs, Hospitality, Housing Care Facilities, Schools, Retail | Both devices have similar intended use environments. Therefore, Substantially Equivalent | | Target Patient Population | General Public | General Public | Both devices have identical targeted patient populations. Therefore, Substantially Equivalent | | Contraindicati ons | None | None Stated | Both devices have no, or no known contraindications. Therefore, Substantially Equivalent. | | Warnings | As it appears on the mandrel: *WARNING* This cuff is not designed for very large arms. Your arm should fit comfortably with your palm on the arm rest. DO NOT FORCE YOUR ARM INTO THE CUFF, AS DISCOMFORT OR INJURY MAY OCCUR. TO RELEASE PRESS THE RED STOP BUTTON As it appears in the manual: Warning, this machine may bruise you, and you may faint while using it. Do not use it if you are sensitive to pressure on your arm, or have experienced fainting or dizziness. If the pressure on your arm bothers you, or if unexpected readings are obtained, immediately touch the 'STOP' button to deflate the cuff. | Warning This cuff is not designed for very large arms. DO NOT FORCE YOUR ARM INTO THE CUFF, TEMPORARY DISCOMFORT OR INJURY MAY OCCUR. Your arm should fit comfortably, with your elbow and forearm on the arm rest. TO RELEASE, PRESS THE STOP BUTTON. | Because both devices use the same blood pressure cuff mandrel, they have identical warnings on it. The predicate device manual does not contain any cautions, warnings or other use restrictions while the proposed device does, including a description of the circumferences that the NIBP module and cuff were designed to operate under. These additional warnings can help aid patient safety. The manual of the proposed device includes a section on Warnings, Safety precautions and Restriction on use. The predicate device does not. The inclusion of a restriction for use on neonatal, pregnant and pre- | | Feature | HealthChek Network Model HCK - 2000 (Health Station System Under Review) | StayHealthy HealthCENTER Biometric Screening Kiosk (Cleared under K123539) | Substantial Equivalence Comments | | Use limitations FDA Product Code | administrator. If you are concerned about your blood pressure, please discuss with a medical professional Warnings, Safety Precautions and Restrictions on Use WARNING, the blood pressure measurement is not intended for use on neonatal, pregnant, or pre- eclamptic patients. When taking blood pressure. The recommended position is comfortably seated, relaxed, legs uncrossed, feet flat on the floor, middle of cuff at level of heart right atrium. It is recommended that 5 minutes should elapse before the first reading is taken. Any reading can be affected by the measurement site, the position of the patient, exercise, the patient's physiologic condition, common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia, renal diseases, patient motion, trembling or shivering. Readings can also be affected by extremes in temperature, humidity, and altitude. If unexpected readings are obtained, contact your physician immediately As it appears in the manual and onscreen: WARNING, the circumference of user's arm should be within 24-38cm (9.5 to 15 inches) for best results It is not a diagnostic device and only furnishes data so that users can consult their personal physicians or other healthcare professional. DXN (Noninvasive blood pressure measurement system) FRW (Weight) | It is not a diagnostic device and only furnishes data so that users can consult their personal physicians or other healthcare professional • DXN (Noninvasive blood pressure measurement system) • HIT (Color vision tester) • MNW (Impedance plethysmograph) | eclamptic patients is in compliance with IEC 80601-2-30 clause 201.7.9.2.1 2. These additional restrictions on use can help aid patient safety Therefore, Substantially Equivalent Both devices have identical use limitations. Therefore, Substantially Equivalent Both devices use the same FDA product code for the regulated aspect of blood pressure measuring. The predicate device did not list product code FRW even though it measures weight; their omission does not have an impact on the substantial equivalence determination. The predicate device includes alternative features and therefore cites additional FDA product codes. However, the additional features do not substantially deviate from either device's intended use as a general health and well-being monitoring system and do not raise any concerns for safety and effectiveness. Therefore, Substantially Equivalent | | Measured Physiological Parameters – From 510(k) | Blood pressure, BP (uses the SunTech Advantage Model 2 module, containing the ct3.39.0 firmware and equipped with the SunTech Kiosk Cuff (part # 98-0231-00-AD. REV B); capable of recording blood pressures from +40 to +260 mm Hg Systolic and +20 to +200 mmHg Diastolic • Heart rate (calculated via the BP module) capable of recording rates from 30 to 220 beats per minute • BMI (Body Mass Index) (via a calculated value using the NIH's algorithms using a height value | • Blood pressure, BP (uses the SunTech Advantage Model 2 module, containing the ct3.39.0 firmware and equipped with the SunTech Kiosk Cuff (part # 98-0231-00-AD. REV B); capable of recording blood pressures from +40 to +260 mm Hg Systolic and +20 to +200 mm Hg Diastolic • Heart rate (calculated via the BP module) capable of recording rates from 30 to 220 beats per minute | Both devices measure blood pressure and heart rate using the same third party blood pressure module. Both devices measure weight using a load cell. The proposed device measure BMI while the predicate device measures percent lean & fat mass. The predicate device also tests for color blindness which the proposed device does not do. However, these features do not substantially change the overall | | | HealthChek Network Health Station Traditional 510(k) Submission | 005_VOL_002_003_Traditional 510(k) Summary - REVISED.docx Confidential | Page 002/003-4 | | | HealthChek Network Model HCK - 2000 (Health Station System Under Review) | StayHealthy HealthCENTER Biometric Screening Kiosk (Cleared under K123539) | Substantial Equivalence Comments | | Feature | entered by the user) No indicated range as this is a function of height and weight • Body weight, (tested at 440 lbs / 200 kg) (as measured via a load cell imbedded in an ADA compliant seat) | • Percent lean body mass (via bioimpedance) • Percent body fat (via bioimpedance) • Percent total body water (via bioimpedance) • Body weight, (up to 500 pounds / 227 kg) (via a load cell imbedded in an ADA compliant seat) • If the user may have color blindness | design intention of the device and the differences in parameters can be considered to be "marketing" features | | Additional / Alternative Measured Physiological Parameters – From Website | None | • Hydration-The Stayhealthy Hydration Index (SHI), which calculates on an individual basis, your specific hydration status based on broad population averages and studies. • On the graph showing your hydration results is a line marked with zero. This represents the threshold for acceptable hydration, and should be considered the minimum level of hydration your body needs. A measurement above zero is desirable. • Each person's zero point is calculated by determining the hydration of their lean mass (everything except fat), plus the water contained in their body fat. Just as physical makeup varies from person to person, so does the zero point | The predicate device offers the measurement of "hydration" as an additional/alternative physiological parameter. However, this feature does not substantially change the overall design intention of the device and can be considered to be a "marketing" feature. Therefore, Substantially Equivalent | | Device Options | • Printer for results • Barcode scanner (2D) • Data Ports for Personal Health Devices:-USB: Used for pedometer download., • Ethernet Connection: Ability to connect to the HealthChek database though built-in Ethernet port | • Printer for results / incentives / coupons • Barcode scanner (2D) • Personal health device upload ports: IR, USB mini, micro, Type A (Download stations for Omron Pedometers and for blood glucose meters) • 32-inch LCD HD display screen (for Advertising, Information and Store messaging) • Wi-Fi or cellular connectivity • Loyalty Card reader - so customer can access an online account | In regards to device options, the predicate device allows for the use of a 32" LCD screen which is used for advertising purposes as well as the use of a "loyalty card" which is also a brand-identification feature that does not change the overall indication for use. The proposed device does not include WiFi or cellular connectivity, but does include an Ethernet connection that is used to store patient-data. Unlike the predicate wherein their WiFi / cellular connection is used to transmit data to the personal physician. Allowing the user to conveniently store and retrieve their data is a marketing feature and does not affect patient safety. Therefore, Substantially Equivalent | | | | COMPARISON OF ERGONOMICS/HUMAN FACTORS | | | | | | | | User Input Mechanism | Touch screen interface | 17 inch LCD touch screen user navigationBP "Express" feature | Both devices use a touch screen; the size of the screen is immaterial. Therefore, Substantially Equivalent | | Data Output / Display Mechanisms | • On-Screen Display • Built-in 200 dpi Printer…